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Name:Assured Acne Cream
Manufacturer:Hangzhou Mino Daily Chemicals Co.ltd.
Category:Over-the-counter (OTC) Marketed Drugs


ASSURED ACNE CREAM  - salicylic acid cream 
HANGZHOU MINO DAILY CHEMICALS CO.LTD.

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

Active Ingredient


Salicylic Acid  0.5%

Purpose


Acne Treatment

Warnings

For external use only

  • flammable, keep away from fire and flame
  • will produce serious gastric disturbances if taken internally

Ask a doctor before use if you have deep puncture wounds or serious burns

When using this product

  • do not get into eyes or mucous membranes
  • use only in a well-ventilated area

Stop use and ask a doctor if condition persists or gets worse.

Keep out of reach of children. In case of an accidental ingestion, contact a Poison Control Center immediately.

Use

for the treatment of acne.

For external use only.

Do not use if you have very sensitive skin or are sensitive to Salicylic Acid.

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 eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth.

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

Directions

Cleanse the skin thoroughly before applying medication. Apply cream directly on acne pimples. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome occurs, reduce application to once a day.

Other information

store between 20 to 25 C (66 to 77 F)

Inactive ingredients

carbomer, cetyl alcohol, dimethicone, glycerin, glycol stearate, methylparaben, propylene glycol, propylparaben, squalane, triethanolamine, water.

Package Label

Acne CreamEnter section text here


ASSURED ACNE CREAM 
acne cream cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:35038-200
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID .5 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER 74.5 mL  in 100 mL
SQUALANE 10 mL  in 100 mL
PROPYLENE GLYCOL 5 mL  in 100 mL
CETYL ALCOHOL 3.5 mL  in 100 mL
GLYCERIN 3 mL  in 100 mL
GLYCOL STEARATE 2 mL  in 100 mL
DIMETHICONE 1 mL  in 100 mL
METHYLPARABEN .2 mL  in 100 mL
PROPYLPARABEN .1 mL  in 100 mL
TROLAMINE .1 mL  in 100 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:35038-200-01 44 mL in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 06/01/2010

Labeler - HANGZHOU MINO DAILY CHEMICALS CO.LTD. (527974203)
Establishment
Name Address ID/FEI Operations
HANGZHOU MINO DAILY CHEMICALS CO.LTD. 527974203 manufacture

Revised: 12/2010 HANGZHOU MINO DAILY CHEMICALS CO.LTD.



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


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