ZINC OXIDE by Delsam Pharma Llc ZINC OXIDE ointment

ZINC OXIDE by

Drug Labeling and Warnings

ZINC OXIDE by is a Otc medication manufactured, distributed, or labeled by Delsam Pharma Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Zinc oxide USP 20%

Purpose

Skin protectant

Uses

helps treat and prevent diaper rash  dries the oozing and weeping of:  poison ivy  poison oak  poison sumac

Warnings

For external use only

When using this product  avoid contact with eyes

Stop use and ask a doctor if  conditions worsens  symptoms last more than 7 days or clear up and occur again within a few days

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.

Directions

For diaper rash

change wet and soiled diapers promptly, allow to dry

apply ointment liberally with each diaper change especially at bedtime or anytime when exposure to wet diapers may be prolonged

To dry the oozing and weeping of poison ivy, poison oak, or poison sumac

apply ointment liberally as often as needed.

Inactive ingredients

Mineral Oil, White Petroleum Jelly

Other information

do not use if seal is punctured or is not visible  use cap to puncture seal  store at room temperature  do not exceed 30°C (86°F)

Questions or comments?

1-866-826-1306 between 9 am and 4 pm EST, Monday- Friday.

SPL UNCLASSIFIED SECTION

Distributed by:

Delsam Pharma Llc

Bronx, Newyork 10467.

Packaging

INGREDIENTS AND APPEARANCE

ZINC OXIDE 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72570-109
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	white (white to off white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72570-109-30	1 in 1 CARTON	09/25/2018
1		30 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	09/25/2018

Labeler - Delsam Pharma Llc (081369679)