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 Derma Sciences Canada Inc., Derma Sciences Canada, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 20%

WHEN USING

When using this product

• do not get into eyes

INACTIVE INGREDIENT

light mineral oil, petrolatum

DO NOT USE

Do not use on

• deep puncture wounds
• animal bites
• serious burns

PURPOSE

Skin Protectant

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 or 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.

KEEP OUT OF REACH OF CHILDREN

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

QUESTIONS

Questions?

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

STORAGE AND HANDLING

Other Information

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

avoid excessive heat

DOSAGE & ADMINISTRATION

Directions

• apply as needed

INDICATIONS & USAGE

Uses

dries the oozing and weeping of:

■ poison ivy ■ poison oak ■ poison sumac

STOP USE

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

ASK DOCTOR

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZINC OXIDE 
zinc oxide ointment ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64772-201
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)	0.75 g  in 1 g
LIGHT MINERAL OIL (UNII: N6K5787QVP)	0.05 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: 64772-201-01	453.6 g in 1 JAR; 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 Drug	M016	11/03/2014

Labeler - Derma Sciences Canada Inc. (200564891)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Sciences Canada, Inc		200564891	manufacture(64772-201) , label(64772-201)