Label: CVS ACNE TREATMENT- resorcinol, sulfur cream
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-813-68 - Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated July 10, 2010
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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.
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CVS ACNE TREATMENT
resorcinol, sulfur creamProduct 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
