RUGBY ZINC OXIDE- zinc oxide ointment

Rugby Zinc Oxide by

Drug Labeling and Warnings

Rugby Zinc Oxide by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Zinc oxide 20%

Purpose

Skin Protectant

Uses

• helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.
• dries the oozing and weeping of poison ivy, poison oak and poison sumac.

Warnings

For external use only

When using this product, avoid contact with the eyes

Stop use and ask a doctor if condition worsens or does not improve within 7 days

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

• apply liberally as often as necessary

For diaper rash:

• change wet or soiled diapers promptly
• cleanse the diaper area and allow to dry
• apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged

Inactive ingredients

mineral oil, petrolatum

Questions or comments?

Call 1-800-645-2158 9 am - 5 pm EST, Monday – Friday

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

R0507

PRINCIPAL DISPLAY PANEL

Principal Display Panel – Jar Label

Rugby® NDC: 0536-5700-98
SKIN PROTECTANT

Zinc Oxide
Ointment USP
provides soothing relief from poison ivy,
oak and sumac
Treats and prevents diaper rash

Net Wt 1 lb (454 g)

distributed by : Rugby Laboratories
17177N Laurel Park Drive Suite 233,Livonia, MI48152 

Principal Display Panel - 30 g Tube

Rugby Zinc Oxide Ointment USP

Skin protectant Zinc Oxide 20%

Help Soothe & Protect Chafed Skin

NET WT 30G (1.05oz)

Principal Display Panel - 30 g Carton

Rugby Zinc Oxide Ointment USP

Skin protectant Zinc Oxide 20%

Help Soothe & Protect Chafed Skin

NET WT 30G (1.05oz)

INGREDIENTS AND APPEARANCE

RUGBY ZINC OXIDE 
zinc oxide ointment

Product 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)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	MANUFACTURE(0536-5700)