CVS ACNE SPOT TREATMENT- salicylic acid gel

CVS Acne Spot Treatment by

Drug Labeling and Warnings

CVS Acne Spot Treatment by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                 Purpose

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

PURPOSE

Uses for the treatment of acne

KEEP OUT OF REACH OF CHILDREN

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.

INDICATIONS & USAGE

Uses for the treatment of acne

WARNINGS

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS ACNE SPOT TREATMENT 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-055
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-055-56	1 in 1 CARTON
1		22 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333D	07/10/2010

Labeler - CVS Pharmacy (062312574)

Registrant - Pharma Pac, LLC (140807475)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Pac, LLC		140807475	manufacture