Label: QUALITY CHOICE DIAPER RASH- zinc oxide ointment
- NDC Code(s): 63868-948-04
- Packager: Chain Drug Marketing Association Inc.
- 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 May 23, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Uses
- Keep out of the reach of children.
- Warnings
- Directions
- Stop use and ask a doctor if
- Other Information:
- Questions
- Inactive Ingredients
- Helps treat and prevent diaper rash. Protects skin. Relieves Chafing. Promotes Healing
- Other Information
- Packaging
-
INGREDIENTS AND APPEARANCE
QUALITY CHOICE DIAPER RASH
zinc oxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-948 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 40 g in 100 g Inactive Ingredients Ingredient Name Strength TALC (UNII: 7SEV7J4R1U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) LANOLIN (UNII: 7EV65EAW6H) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) COD LIVER OIL (UNII: BBL281NWFG) LIGHT MINERAL OIL (UNII: N6K5787QVP) METHYLPARABEN (UNII: A2I8C7HI9T) PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-948-04 113 g in 1 TUBE; Type 0: Not a Combination Product 12/19/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 12/19/2019 Labeler - Chain Drug Marketing Association Inc. (011920774) Registrant - Trifecta Pharmaceuticals USA LLC (079424163)