ZINC OXIDE- zinc oxide ointment ointment

Zinc Oxide by

Drug Labeling and Warnings

Zinc Oxide by is a Otc medication manufactured, distributed, or labeled by Gentell, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 20%

PURPOSE

Skin Protectant

INDICATIONS & USAGE

Uses

dries the oozing and weeping of:

• poison ivy
• poison oak
• poison sumac

WARNINGS

Warnings

For external use only

When using this product

• do not get into eyes

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

Do not use on

• deep puncture wounds
• animal bites
• serious burns

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

When using this product

• do not get into eyes

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

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

Do not use on

• deep puncture wounds
• animal bites
• serious burns

Keep out of reach of children.

For external use only

If swallowed, get medical help or contact a Poison Control Center right away.

INSTRUCTIONS FOR USE

Directions

• apply as needed

apply as needed

STORAGE AND HANDLING

Other Information

store between 15ºC to 30ºC (59ºF to 86ºF)

avoid excessive heat

INACTIVE INGREDIENT

Inactive ingredients

light mineral oil, petrolatum

QUESTIONS

Questions?

Call 800-840-9041 Monday through Friday 9:00 AM to 5:00 PM EST

PRINCIPAL DISPLAY PANEL

Gentell ® We make it better

GEN-23400

Zn Oxide

Zinc Oxide Ointment

Skin Protectant

16 oz. (454g)

Gentell 2701 Bartram Road, Bristol, PA 19007 www.gentell.com

INGREDIENTS AND APPEARANCE

ZINC OXIDE 
zinc oxide ointment ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61554-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.2 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP)	0.05 g  in 1 g
PETROLATUM (UNII: 4T6H12BN9U)	0.75 g  in 1 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: 61554-100-02	453.6 g in 1 JAR; Type 0: Not a Combination Product	11/03/2014
2	NDC: 61554-100-01	28.3 g in 1 TUBE; Type 0: Not a Combination Product	11/03/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	11/03/2014

Labeler - Gentell, Inc. (170967876)

Establishment
Name	Address	ID/FEI	Business Operations
Gentell, Inc.		170967876	manufacture(61554-100)