CVS ACNE TREATMENT- resorcinol, sulfur cream

CVS ACNE TREATMENT by

Drug Labeling and Warnings

CVS ACNE 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

Resorcinol 2%............................................Acne medication
Sulfur 8%...................................................Acne Medication

PURPOSE

Uses for the treatment and prevention of acne pimples

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Use for the treatment and prevention of acne pimples

WARNINGS

Warnings

For external use only


Do not use - on broken skin - on large areas of the body


When using this product
- apply to affected areas only
- avoid contact with the eyes, lips and mouth
- with 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.

Stop use and ask a doctor if excessive skin irritation develops or increases

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

DOSAGE & ADMINISTRATION

Directions

- Cleanse the skin thoroughly before applying medication
- Cover the affected area with a thin layer one to three times a day
- because excessive drying of the skin may occur, start with one application daily,
then gradually increase to two to three times 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.
- use to prevent new pimples from forming

Other information

- keep tightly closed
- keep away from heat

INACTIVE INGREDIENT

Inactive Ingredients


Water, SD Alcohol 40B, Bentonite, Glyceryl Stearate SE, Propylene Glycol,
Titanium Dioxide, Isopropyl Myristate, Fragrance, Iron Oxides, Simethicone,
Methylparaben, Propylparaben

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS ACNE TREATMENT 
resorcinol, sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-813
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK)	RESORCINOL	20 mg  in 1 g
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	80 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BENTONITE (UNII: A3N5ZCN45C)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
DIMETHICONE (UNII: 92RU3N3Y1O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TALC (UNII: 7SEV7J4R1U)
ALCOHOL (UNII: 3K9958V90M)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-813-68	1 in 1 CARTON
1		18 g 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