ATOPALM ACNE CONTROLLING  - salicylic acid lotion 
NeoPharm 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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Atopalm Acne Controlling Lotion

Active Ingredient

Active Ingredient..................................Purpose
Salicylic Acid 2% ..................Acne Medication

Use

for the treatment of acne

Warnings

For external use only.

When using this product

- avoid contact with the eyes. If product gets into the eyes, rinse thoroughly with water. - using with other topical acne medications, at the same time, or immediately following use of this product, may increase dryness or irritation of the skin. If this occurs, only one acne medication should be used unless directed by your doctor. - limit use to face and neck

Stop use and ask a doctor

if skin or eye irritation develops.

Keep out of reach of children

Keep out of reach of children.

Ask Doctor

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

cleanse skin thoroughly before applying medication - cover entire affected area with a thin layer one to three times daily - because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 or 3 applications 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.

Other information

- store in a cool, dry place - keep outer packaging for precautions and directions

Inactive Ingredients

Water, Butylene Glycol, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Octyldodecanol, Polysorbate 60, Arginine, Stearic Acid, Myristoyl/Palmitoyl Oxostearamide/Arachamide MEA, Tocopheryl Acetate, Allantoin, Cholesterol, Xanthan Gum, Polyacrylamide, Methylparaben, Fragrance, Propylparaben, C13-14 Isoparaffin, Laureth-7.

Questions or information

Questions or information call toll free: 1-855 - ATOPALM

Purpose

Acne Medication

Description

US Patent # US 6221371B1  Distributed by: Neopharm USA, 1 Oyster Bay Drive, Rumson, NJ 07760 Made in Korea 75721  Quick absorbing all over face lotion has a salicylic based formula that works through the night to help visibly reduce redness and reduce the size of existing pimples.


ATOPALM ACNE CONTROLLING LOTION  With US Patented MLE Technology  With 2% Salicylic Acid-Acne Medication to help reduce the appearance of redness and pimple size overnight 1.3 fl oz /38.4 ml  Drug Facts
Active Ingredient............................. ....................Purpose
Salicylic Acid 2% ................................. Acne Medication
Use for the treatment of acne  Warnings For external use only.  When using this product - avoid contact with the eyes. If product gets into the eyes, rinse thoroughly with water. - using with other topical acne medications, at the same time, or immediately following use of this product, may increase dryness or irritation of the skin. If this occurs, only one acne medication should be used unless directed by your doctor. - limit use to face and neck  Stop use and ask a doctor if skin or eye irritation develops.  Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.  Directions cleanse skin thoroughly before applying medication - cover entire affected area with a thin layer one to three times daily - because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 or 3 applications 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.  Other information - store in a cool, dry place - keep outer packaging for precautions and directions  Questions or information call toll free: 1-855-ATOPALM  Distributed by: Neopharm USA, 1 Oyster Bay Drive, Rumson, NJ 07760  Made in Korea  75721

ATOPALM  ACNE CONTROLLING LOTION  US Patent # US 6221371B1  Distributed by: Neopharm USA, 1 Oyster Bay Drive, Rumson, NJ 07760 Made in Korea 75721

ATOPALM  ACNE CONTROLLING LOTION  Dermatologist Tested  ATOPALM ACNE CONTROLLING LOTION  ATOPALM ACNE CONTROLLING LOTION  2% Salicylic Acid  Acne Medication  Quick absorbing all over face lotion has a salicylic based formula that works through the night to help visibly reduce redness and reduce the size of existing pimples.  With US Patented M L E Technology  Helps Visibly Reduce Redness and Reduce Pimple Size Overnight  1.3 fl oz /38.4 ml  8  57811 00221  7

Product Package Inner Label

Atopalm Acne Inner Package

Product Package Outer Label 1

Atopalm Acne Outer Package 1

Product Package Outer Label 2

Atopalm Acne Outer Package 2

ATOPALM ACNE CONTROLLING  
salicylic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-7000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
ARGININE (UNII: 94ZLA3W45F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)  
ALLANTOIN (UNII: 344S277G0Z)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51141-7000-11 in 1 CARTON
138.4 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D11/04/2011
Labeler - NeoPharm Co., Ltd. (965502912)
Establishment
NameAddressID/FEIBusiness Operations
NeoPharm Co., Ltd.631101883manufacture

Revised: 11/2011
Document Id: 7504a18f-1c22-4f87-95f3-97b65a9a9976
Set id: 3049dca0-1ce5-4dee-95c0-b3563cbc511b
Version: 2
Effective Time: 20111109
 
NeoPharm Co., Ltd.