Rugby Zinc Oxide Ointment 20%

Rugby Zinc Oxide by

Drug Labeling and Warnings

Rugby Zinc Oxide by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, ANICARE PHARMACEUTICALS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RUGBY ZINC OXIDE- zinc oxide 20% ointment 
Rugby Laboratories

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.

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Rugby Zinc Oxide Ointment 20%

Active Ingredient

Zinc Oxide 20%

Purpose

Skin Protectant

Uses

Dries the oozing and weeping of poison: Ivy Oak Sumac

Warnings

For External Use Only

When using this product

Avoid contact with eyes

Do not use over large areas of the body

Stop use and ask a doctor if

• Condition worsens

Symptoms last more than 7 days or clear up and occur again within a few days

If you are allergic to any of these ingredients

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

For poison ivy, oak, and sumac: apply as needed.

Other Information

Store at room temperature between 15°-30°C (59°-86°F)

Avoid excessive heat

Inactive Ingredients

Cetomacrogol 1000, Cetostearyl Alcohol, Light liquid paraffin (Mineral Oil), Petrolatum

Questions and Comments?

Toll free 1-866-326-1313

RUGBY ZINC OXIDE 
zinc oxide 20% ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1393
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 (UNII: I835H2IHHX)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color		Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1393-98	1 in 1 BOX	07/01/2023
1		454 g in 1 JAR; 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	07/01/2023

Labeler - Rugby Laboratories (079246066)

Establishment
Name	Address	ID/FEI	Business Operations
ANICARE PHARMACEUTICALS PRIVATE LIMITED		916837425	manufacture(0536-1393)

Revised: 7/2023

Document Id: 00c4baa1-9811-f0ad-e063-6294a90a6759

34390-5

Set id: 00c4c849-7db9-8264-e063-6394a90ab5f9

Version: 1

Effective Time: 20230718