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Name:Benzoyl Peroxide
Manufacturer:Wal-mart Stores Inc
Category:Over-the-counter (OTC) Marketed Drugs


drug facts

BENZOYL PEROXIDE  -     
Wal-Mart Stores Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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drug facts

Purifying Cleanser

Active ingredient                      Purpose
Benzoyl Peroxide 2.5%..............Acne Treatment

Purifying Cleanser

Active ingredient                      Purpose
Benzoyl Peroxide 2.5%..............Acne Treatment

Use for the management of acne

Purifying Cleanser Warning Section

Warnings

For external use only

Do not use this medication if you have very sensitive
skin or if you are very sensitive to benzoyl peroxide.

Ask a doctor or pharmacist before use if you are
using  other topical acne medications at the same
time or immediately following use of this product.
This may increase dryness or irritation of the skin.
If this occurs, only one medication should be used
unless directed by a doctor.

When using this product
- avoid contact with the eyes. If contact occurs,
rinse eyes thoroughly with water.
- keep away from lips and mouth
- aviod unnecessary sun exposure and use a
sunscreen

Stop use and ask a doctor if skin irritation occurs.

Keep out of the reach of children. If swallowed, get
medical help or contact a Poison Control Center right
away.

Purifying Cleanser Directions Section

Directions

- Use morning and night. Apply a small (dime sized)
amount to dampened skin and gently massage for
1 to 2 minutes.
- Rinse thoroughly with warm water
- Pat dry
- If bothersome dryness or peeling occurs, reduce
application to once a day or every other day

- If going outside, use a sunscreen

Other information

- This product may bleach hair or dyed fabrics
- Avoid storing at extreme temperatures (below 40
degrees F and above 100 degrees F)

Purifying Cleanser Warning Section

Warnings

For external use only

Do not use this medication if you have very sensitive
skin or if you are very sensitive to benzoyl peroxide.

Ask a doctor or pharmacist before use if you are
using  other topical acne medications at the same
time or immediately following use of this product.
This may increase dryness or irritation of the skin.
If this occurs, only one medication should be used
unless directed by a doctor.

When using this product
- avoid contact with the eyes. If contact occurs,
rinse eyes thoroughly with water.
- keep away from lips and mouth
- aviod unnecessary sun exposure and use a
sunscreen

Stop use and ask a doctor if skin irritation occurs.

Keep out of the reach of children. If swallowed, get
medical help or contact a Poison Control Center right
away.

Purifying Cleanser Directions Section

Directions

- Use morning and night. Apply a small (dime sized)
amount to dampened skin and gently massage for
1 to 2 minutes.
- Rinse thoroughly with warm water
- Pat dry
- If bothersome dryness or peeling occurs, reduce
application to once a day or every other day

- If going outside, use a sunscreen

Other information

- This product may bleach hair or dyed fabrics
- Avoid storing at extreme temperatures (below 40
degrees F and above 100 degrees F)



Purifying Cleanser inactive ingredients section

Inactive Ingredients
purified water, disodium PEG-12 dimethicone
sulfosuccinate, magnesium aluminum silicate,
gyyceryl stearate, tridecyl stearate, neopentyl
glycol dicaprylate/dicaprate, tridecyl trimelliate,
PEG-100 Stearate, sorbitol, dimethyl isosorbide,
polyethylene, cetyl esters, anthemis nobilis flower
extract, xanthan gum, propylene glycol,
imidazolidinyl urea, sodium hyaluronate, sodium
PCA, methylparaben, propylparaben, fragrance

front panel

drugfacts

Carton Side


Repairing Lotion

Active ingredient                      Purpose
Benzoyl Peroxide 2.5%..............Acne Treatment


Repairing Lotion

Active ingredient                      Purpose
Benzoyl Peroxide 2.5%..............Acne Treatment

Use for the management of acne

Repairing Lotion Warning Section

Warnings

For external use only

Do not use this medication if you have very sensitive
skin or if you are very sensitive to benzoyl peroxide.

Ask a doctor or pharmacist before use if you are
using  other topical acne medications at the same
time or immediately following use of this product.
This may increase dryness or irritation of the skin.
If this occurs, only one medication should be used
unless directed by a doctor.

When using this product
- avoid contact with the eyes. If contact occurs,
rinse eyes thoroughly with water.
- keep away from lips and mouth
- aviod unnecessary sun exposure and use a
sunscreen

Stop use and ask a doctor if skin irritation occurs.

Keep out of the reach of children. If swallowed, get
medical help or contact a Poison Control Center right
away.

Repairing Lotion Directions Section

Directions

- Cleanse the skin thoroughly before applying
medication
- Cover the entire affected area with a thin layer 1 to
3 times daily
- Because excessive drying of the skin may occur,
start with 1 application daily, then gradually
increase to 2 or 3 times daily, if needed or as
directed by a doctor. If bothersome dryness or
peeling occurs, reduce application to once a day or
every other day
- If going outside, use a sunscreen


Other information


- This product may bleach hair or dyed fabrics
- Avoid storing at extreme temperatures
(below 40 degrees F and above 100 degrees F)

Repairing Lotion Warning Section

Warnings

For external use only

Do not use this medication if you have very sensitive
skin or if you are very sensitive to benzoyl peroxide.

Ask a doctor or pharmacist before use if you are
using  other topical acne medications at the same
time or immediately following use of this product.
This may increase dryness or irritation of the skin.
If this occurs, only one medication should be used
unless directed by a doctor.

When using this product
- avoid contact with the eyes. If contact occurs,
rinse eyes thoroughly with water.
- keep away from lips and mouth
- aviod unnecessary sun exposure and use a
sunscreen

Stop use and ask a doctor if skin irritation occurs.

Keep out of the reach of children. If swallowed, get
medical help or contact a Poison Control Center right
away.

Repairing Lotion Directions Section

Directions

- Cleanse the skin thoroughly before applying
medication
- Cover the entire affected area with a thin layer 1 to
3 times daily
- Because excessive drying of the skin may occur,
start with 1 application daily, then gradually
increase to 2 or 3 times daily, if needed or as
directed by a doctor. If bothersome dryness or
peeling occurs, reduce application to once a day or
every other day
- If going outside, use a sunscreen


Other information


- This product may bleach hair or dyed fabrics
- Avoid storing at extreme temperatures
(below 40 degrees F and above 100 degrees F)

Repairing Lotion inactive ingredients section

Inactive ingredients
purified water, cetearyl alcohol, ceteareth-20,
ethoxydiglycol, cyclotetrasiloxane, propylene
glycol, dimethicone, glyceryl stearate,
cyclopentasiloxane diazolidinyl urea, methylparaben,
propylparaben, PEG-100 stearate, panthenol,
allantoin, triethanolamine, carbomer, fragrance,
xanthan gum
 

BENZOYL PEROXIDE 
benzoyl peroxide kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-021
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49035-021-13 1 KIT ( CARTON) in 1 KIT None
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE, PLASTIC   120 mL
Part 2 1 BOTTLE, PLASTIC   60 mL
Part 1 of 2
BENZOYL PEROXIDE 
benzoyl peroxide cream
Product Information
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 36.9 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
MAGNESIUM ALUMINUM SILICATE  
GLYCERYL MONOSTEARATE  
POLYOXYL 100 STEARATE  
PEG-12 STEARATE  
SORBITOL  
DIMETHYL ISOSORBIDE  
TRIDECYL STEARATE  
NEOPENTYL GLYCOL  
HIGH DENSITY POLYETHYLENE  
CETYL ESTERS WAX  
CHAMAEMELUM NOBILE FLOWER  
HYALURONATE SODIUM  
SODIUM PYRROLIDONE CARBOXYLATE  
XANTHAN GUM  
IMIDUREA  
METHYLPARABEN  
PROPYLPARABEN  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 120 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333D 02/26/2010

Part 2 of 2
BENZOYL PEROXIDE 
benzoyl peroxide lotion
Product Information
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 36.9 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water  
DIETHYLENE GLYCOL MONOETHYL ETHER  
POLYOXYL 20 CETOSTEARYL ETHER  
CETOSTEARYL ALCOHOL  
PROPYLENE GLYCOL  
DIMETHICONE  
GLYCERYL MONOSTEARATE  
METHYLPARABEN  
DIAZOLIDINYL UREA  
PROPYLPARABEN  
PANTHENOL  
ALLANTOIN  
XANTHAN GUM  
CARBOMER HOMOPOLYMER TYPE C  
POLYOXYL 100 STEARATE  
TROLAMINE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 60 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333D 02/26/2010


Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333D 02/26/2010

Labeler - Wal-Mart Stores Inc (051957769)
Registrant - Pharma Pac, LLC (140807475)
Establishment
Name Address ID/FEI Operations
Pharma Pac, LLC 140807475 manufacture

Revised: 02/2011 Wal-Mart Stores Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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