Label: RUGBY ZINC OXIDE- zinc oxide ointment
- NDC Code(s): 0536-5700-25, 0536-5700-28, 0536-5700-98
- Packager: Rugby Laboratories
- 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 13, 2021
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
- Inactive ingredients
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- PRINCIPAL DISPLAY PANEL
- Principal Display Panel - 30 g Tube
- Principal Display Panel - 30 g Carton
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INGREDIENTS AND APPEARANCE
RUGBY ZINC OXIDE
zinc oxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-5700 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 200 mg in 1 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-5700-98 454 g in 1 JAR; Type 0: Not a Combination Product 03/23/2004 2 NDC:0536-5700-28 1 in 1 CARTON 09/24/2018 2 30 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:0536-5700-25 1 in 1 CARTON 09/06/2018 3 60 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 03/23/2004 Labeler - Rugby Laboratories (079246066)