CVS ACNE TREATMENT - resorcinol, sulfur cream 
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

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



Uses
for the treatment and prevention of acne pimples


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



Use for the treatment and prevention of acne pimples

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.


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 Ingredients


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


c

CVS ACNE TREATMENT 
resorcinol, sulfur cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-813
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL20 mg  in 1 g
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR80 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-813-681 in 1 CARTON
118 g 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: 309dfa96-35c0-4c59-ae92-ba543c3dd666
Set id: 0dccffab-8f73-4bdb-ad90-0b668b556ce3
Version: 1
Effective Time: 20100710
 
CVS Pharmacy