Label: MAXIMUM STRENGTH DIAPER RASH- zinc oxide ointment ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-849-04 - Packager: CVS Pharmacy
- 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 January 29, 2021
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions for Use
- Other information
- Inactive ingredients
- Package label
- Tube label
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INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH DIAPER RASH
zinc oxide ointment ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-849 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 40 g in 100 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) 31 g in 100 g MINERAL OIL (UNII: T5L8T28FGP) 20 g in 100 g PARAFFIN (UNII: I9O0E3H2ZE) 1 g in 100 g CASTOR OIL (UNII: D5340Y2I9G) 3.5 g in 100 g BALSAM PERU (UNII: 8P5F881OCY) 4.5 g in 100 g Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-849-04 113 g in 1 TUBE; Type 0: Not a Combination Product 07/22/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 07/22/2016 Labeler - CVS Pharmacy (062312574) Establishment Name Address ID/FEI Business Operations Unipack, Inc. 009248480 manufacture(59779-849)