Label: DIMETHICONE AND ZINC OXIDE ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-082-02 - Packager: CVS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 February 16, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- change wet and soiled diapers promptly
- cleanse the diaper area and allow to dry
- apply cream liberally as often as necessary with
each diaper change, especially at bedtime or anytime
when exposure to wet diapers may be prolonged
Other information
Store between 20 degrees to 25 degrees C (68 degrees to 77 degrees F)
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DIMETHICONE AND ZINC OXIDE
dimethicone and zinc oxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-082 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 10 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 100 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MINERAL OIL (UNII: T5L8T28FGP) COCONUT OIL (UNII: Q9L0O73W7L) COD LIVER OIL (UNII: BBL281NWFG) GLYCERYL MONOOLEATE (UNII: 4PC054V79P) PARAFFIN (UNII: I9O0E3H2ZE) CERESIN (UNII: Q1LS2UJO3A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WHITE WAX (UNII: 7G1J5DA97F) BENZYL ALCOHOL (UNII: LKG8494WBH) ALOE (UNII: V5VD430YW9) SORBITOL (UNII: 506T60A25R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-082-02 113 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/01/2009 Labeler - CVS (062312574) Registrant - Pharma Pac, LLC (140807475) Establishment Name Address ID/FEI Business Operations Pharma Pac, LLC 140807475 manufacture