Label: DIAPER- zinc oxide ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 71969-111-01, 71969-111-02 - Packager: Medek Laboratories 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 December 3, 2019
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- ACTIVE INGREDIENT
- Purpose
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Other Information
- Inactive Ingredients
- Indications
- Do Not Use
- Ask a doctor
- Directions
- dosage
- image of label
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INGREDIENTS AND APPEARANCE
DIAPER
zinc oxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71969-111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 21.76 g in 100 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) STARCH, CORN (UNII: O8232NY3SJ) LANOLIN (UNII: 7EV65EAW6H) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) CANDELILLA WAX (UNII: WL0328HX19) CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17) TOCOL ACETATE (UNII: 37Z972M0N0) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI) BISABOLOL OXIDE A (UNII: 16AE65F94Y) CHOLESTEROL (UNII: 97C5T2UQ7J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71969-111-01 170 g in 1 JAR; Type 0: Not a Combination Product 03/08/2018 2 NDC:71969-111-02 1 in 1 PACKAGE 04/09/2018 2 57 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 03/08/2018 Labeler - Medek Laboratories Inc. (080332132)