CVS ACNE SPOT TREATMENT - salicylic acid gel 
CVS Pharmacy

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.

----------

DRUG FACTS

Active ingredient                                 Purpose

Salicylic Acid 2%............................................Acne medication



Uses
for the treatment of acne


Keep out of reach of children. If swallowed, get medical help or contact a
Poison Control Center right away. Avoid contact with eyes. If contact occurs,
flush thoroughly with water.



Uses for the treatment of acne

Warnings

For external use only


Flammable, keep away from open fire or flame


When using this product
and other topical acne medications at the same time
or immediately following use of this product, increased dryness or irritation of the skin
may occur. If this occurs, only one medication  should be used unless directed by a doctor.


Keep out of reach of children. If swallowed, get medical help or contact a Poison
Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water.


Directions

- Cleanse skin thoroughly before applying medication
- Cover the affected area entirely up to three times daily
- If excessive dryness or peeling occurs, reduce usage to once a day or every other day
- Recommended for daily use

Inactive Ingredients


alcohol, butylene glycol, capryloyl glycine, cedrus atlantic bark extract, cinnamomum
zeylanicum bark extract, fragrance, glycerin, hexylene glycol, hydroxyethylcellulose,
methylparaben, portulica oleracea extract, propylene glycol, propylparaben, purified water,
sarcosine, sodium citrate


c

CVS ACNE SPOT TREATMENT 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-055
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
MANGANESE GLUCONATE (UNII: 9YY2F980SV)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
CEDRUS ATLANTICA BARK (UNII: ITP1Q41UPF)  
GLYCERIN (UNII: PDC6A3C0OX)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
PURSLANE (UNII: M6S840WXG5)  
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
ALCOHOL (UNII: 3K9958V90M)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
HYDROXYETHYL CELLULOSE (4000 MPA.S FOR 1% AQUEOUS SOLUTION) (UNII: ZYD53NBL45)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-055-561 in 1 CARTON
122 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333D07/10/2010
Labeler - CVS Pharmacy (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 7/2010
Document Id: 04d696fc-a872-4988-bd20-2ae3d7ffd55b
Set id: c9b1a111-7654-4875-9dad-dc6fdbc76883
Version: 1
Effective Time: 20100710
 
CVS Pharmacy