CVS ACNE TREATMENT

Dosage form: cream
Ingredients: RESORCINOL 20mg in 1g, SULFUR 80mg in 1g
Labeler: CVS Pharmacy
NDC Code: 59779-813

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



CVS ACNE TREATMENT 
resorcinol, sulfur cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-813
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RESORCINOL (RESORCINOL) RESORCINOL20 mg  in 1 g
SULFUR (SULFUR) SULFUR80 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
BENTONITE 
GLYCERYL MONOSTEARATE 
TITANIUM DIOXIDE 
ISOPROPYL MYRISTATE 
DIMETHICONE 
FERRIC OXIDE RED 
TALC 
ALCOHOL 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:59779-813-681 TUBE (TUBE) 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/FEIOperations
Pharma Pac, LLC140807475manufacture

Revised: 07/2010
 
CVS Pharmacy

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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