DIAPERRASHOINTMENT- zinc oxide ointment

DiaperRashOintment by

Drug Labeling and Warnings

DiaperRashOintment by is a Otc medication manufactured, distributed, or labeled by Pharmacy Value Alliance, LLC, Trifecta Pharmaceuticals USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Zinc Oxide 40%

Purpose

Skin Protectant

Uses

• Helps treat and prevent diaper rash
• Protects chafed skin due to diaper rash and helps protect skin from wetness

Keep out of the reach of children.

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

Warnings

For External Use Only

When using this product

• Avoid contact with eyes

Directions

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

Stop use and ask a doctor if

• Condition worsens
• Symptoms last more than 7 days or clear up and occur again with a few days

Other Information:

• Store at controlled room temperature 20° - 25°C (68° - 77°F)

Inactive Ingredients

BHA, Cod liver oil (high in vitamin A and D), Frangrance, Lanolin, Mineral Oil, Methylparaben, Petrolatum, Purified water, Talc, Tartrazine yellow #4 (FD and C yellow #4)

Helps treat and prevent diaper rash. Protects skin. Relieves Chafing. Promotes Healing

Distributed by:

Pharmacy Value Alliance, LLC.

407 East Lancaster Avenue, Wayne, PA. 19087 USA

www.emersongroup.com

Packaging

INGREDIENTS AND APPEARANCE

DIAPERRASHOINTMENT 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-128
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	40 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PETROLATUM (UNII: 4T6H12BN9U)
YELLOW WAX (UNII: 2ZA36H0S2V)
STEARIC ACID (UNII: 4ELV7Z65AP)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-128-20	113 g in 1 TUBE; Type 0: Not a Combination Product	02/28/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/22/2016

Labeler - Pharmacy Value Alliance, LLC (101668460)

Registrant - Trifecta Pharmaceuticals USA LLC (079424163)