Label: DENINO DIAPER RASH- rash prevention cream cream
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Contains inactivated NDC Code(s)
NDC Code(s): 50760-8051-6 - Packager: Corpsain SA de CV
- 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 26, 2010
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- Drug Facts
- Directions for use
- WARNINGS
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- REFERENCES
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DENINO DIAPER RASH
rash prevention cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50760-8051 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 7.8 mL in 60 mL AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP .6 mL in 60 mL MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) (MEDIUM-CHAIN TRIGLYCERIDES - UNII:C9H2L21V7U) MEDIUM-CHAIN TRIGLYCERIDES 18.21 mL in 60 mL LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN 2.4 mL in 60 mL Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) WAX, YELLOW (UNII: 2ZA36H0S2V) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50760-8051-6 60 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 04/01/2010 Labeler - Corpsain SA de CV (814593448) Establishment Name Address ID/FEI Business Operations Corpsain SA de CV 814593448 manufacture, label