Quality Choice Diaper Rash: Package Insert and Label Information

QUALITY CHOICE DIAPER RASH- zinc oxide ointment
Chain Drug Marketing Association Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

QUALITY CHOICE DIAPER RASH zinc oxide ointment

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-948 Route of Administration TOPICAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength TALC BUTYLATED HYDROXYTOLUENE LANOLIN FD&C YELLOW NO. 5 COD LIVER OIL LIGHT MINERAL OIL METHYLPARABEN PETROLATUM WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63868-948-04 113 g in 1 TUBE None

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)

Revised: 02/2021 Chain Drug Marketing Association Inc.