QUALITY CHOICE DIAPER RASH- zinc oxide ointment

Quality Choice Diaper Rash by

Drug Labeling and Warnings

Quality Choice Diaper Rash by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association Inc., 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

This product contains trace amounts of naturally occuring lead.

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)

Questions

1-800-935-2362

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:

C.D.M.A., Inc. ©

43157 W 9 Mile Rd

Novi, MI. 48375 USA

www.qualitychoice.com

Product of PRC

Other Information

This product is not manufactured or distributed by Johnson & Johnson Consumer Company Inc. owner of the registered trademark Desitin®.

Packaging

INGREDIENTS AND APPEARANCE

QUALITY CHOICE DIAPER RASH 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-948
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
TALC (UNII: 7SEV7J4R1U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
LANOLIN (UNII: 7EV65EAW6H)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
COD LIVER OIL (UNII: BBL281NWFG)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-948-04	113 g in 1 TUBE; Type 0: Not a Combination Product	12/19/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/19/2019

Labeler - Chain Drug Marketing Association Inc. (011920774)

Registrant - Trifecta Pharmaceuticals USA LLC (079424163)