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Name:Acneclir
Manufacturer:Phillips Company
Category:Over-the-counter (OTC) Marketed Drugs


DRUG FACTS

ACNECLIR  - salicylic acid lotion 
Phillips Company

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

DRUG FACTS

Drug Facts
Active Ingredient               Purpose
Salicylic acid  (2%)           Acne medication
______________________________________
Uses 
n Acne medication lotion.  For the treatment of acne.  Clears up most acne blemishes and allows skin to heal.
______________________________________
Warnings
n For external use only   
n When using this product, skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If irritation occurs, only use one topical acne medication at a time.
n Keep away from children   
n Avoid contact with eyes  
n May be harmful if swallowed or inhaled
______________________________________
Ask a physician
n If symptoms last for more than 7 days or clear up and recur within a few days.
n If the conditions do not improve.  
n Before use on children under 2 years.
n Before use if you are allergic to any ingredients listed on this label.
______________________________________
Directions
n Clean the skin thoroughly before applying this product.
n Apply product sparingly to one or two small affected areas during the first 3 days.  If no discomfort occurs, follow the directions stated below.
n Each morning, cover the entire affected area with a thin layer of this product.
n Apply this  product by rubbing it in.  If any liquid remains on the skin (after a 20-second rub-in), you have applied too much product.
 ______________________________________
Other information   
Store at 40 to 100 degrees F.   Net contents:  3 mL.  This product contains no alcohol; no animal products.              
______________________________________
Inactive ingredients  
Water, dimethyl sulfoxide, dipropylene glycol, ascorbic acid, sorbic acid, magnesium stearate, stearic acid. 
 ______________________________________
Questions and Side effects
Use of this product results in no known side effects when used according to directions.  Phillips Company, 311 Chickasaw Street, Millerton, OK USA 74750;   Tel.  580-746-2430  
Email address:  hp@valliant.net

ACTIVE INGREDIENTS

Active Ingredient               Purpose
Salicylic acid  (2%)           Acne medication

ASK DOCTOR

Ask a physician
n If symptoms last for more than 7 days or clear up and recur within a few days.
n If the conditions do not improve.  
n Before use on children under 2 years.
n Before use if you are allergic to any ingredients listed on this label.


DO NOT USE

n When using this product, skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If irritation occurs, only use one topical acne medication at a time.
n Keep away from children   
n Avoid contact with eyes  
n May be harmful if swallowed or inhaled

CHILDREN

 
Keep away from children   
Avoid contact with eyes  
May be harmful if swallowed or inhaled

PURPOSE

Active Ingredient               Purpose
Salicylic acid  (2%)           Acne medication
______________________________________
Uses 
n Acne medication lotion.  For the treatment of acne.  Clears up most acne blemishes and allows skin to heal.

STOP USE

n When using this product, skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If irritation occurs, only use one topical acne medication at a time.

WHEN USING


For external use only   
Avoid contact with eyes  
May be harmful if swallowed or inhaled
If symptoms last for more than 7 days or clear up and recur within a few days.
If the conditions do not improve.  
Store at 40 to 120 degrees F.

WARNINGS


Warnings
n For external use only   
n When using this product, skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If irritation occurs, only use one topical acne medication at a time.
n Keep away from children   
n Avoid contact with eyes  
n May be harmful if swallowed or inhaled

DOSAGE & ADMINISTRATION

Uses 
n Acne medication lotion.  For the treatment of acne.  Clears up most acne blemishes and allows skin to heal.
______________________________________

Directions
n Clean the skin thoroughly before applying this product.
n Apply product sparingly to one or two small affected areas during the first 3 days.  If no discomfort occurs, follow the directions stated below.
n Each morning, cover the entire affected area with a thin layer of this product.
n Apply this  product by rubbing it in.  If any liquid remains on the skin (after a 20-second rub-in), you have applied too much product.

USE


Uses 
n Acne medication lotion.  For the treatment of acne.  Clears up most acne blemishes and allows skin to heal.
______________________________________

Directions
n Clean the skin thoroughly before applying this product.
n Apply product sparingly to one or two small affected areas during the first 3 days.  If no discomfort occurs, follow the directions stated below.
n Each morning, cover the entire affected area with a thin layer of this product (ACNE22).
n Apply this  product by rubbing it in.  If any liquid remains on the skin (after a 20-second rub-in), you have applied too much product.

INACTIVE INGREDIENTS

Inactive ingredients  
Water, dimethyl sulfoxide, dipropylene glycol, ascorbic acid, sorbic acid, magnesium stearate, stearic acid. 

Image of product

Image of product
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ACNECLIR 
salicylic acid lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43074-110
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 0.02 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
dimethyl sulfoxide  
ascorbic acid  
dipropylene glycol  
water  
sorbic acid  
magnesium stearate  
stearic acid  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43074-110-29 1 BOTTLE, DROPPER ( BOTTLE) in 1 BOX contains a BOTTLE, DROPPER (43074-110-27)
1 NDC:43074-110-27 3 mL in 1 BOTTLE, DROPPER This package is contained within the BOX (43074-110-29)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 12/30/2010

Labeler - Phillips Company (612368238)
Establishment
Name Address ID/FEI Operations
Phillips Company 612368238 manufacture

Revised: 08/2010 Phillips Company



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


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