BabyDiaperCream: Package Insert and Label Information

BABYDIAPERCREAM- zinc oxide cream
Whole Foods Market

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.

Active Ingredients

Zinc Oxide 14.0% ……………………………………….. Skin Protectant

Purpose:

Skin Protectant

Uses:

Helps treat and prevent diaper rash. ■Helps protect against chafed skin due to diaper rash and helps seal out wetness.

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. ■Keep out of the reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

Directions:

■Change wet and soiled diapers promptly. ■Cleanse diaper area and allow to dry. ■Apply diaper cream liberally and as often as necessary to prevent or treat irritation, with each diaper change.

Storage

Store in a cool, dry place

Inactive Ingredients:

Aloe Barbadensis Leaf Juice, Avena Sativa (Oat) Kernel Extract, Avena Sativa (Oat) Kernel Flour, Beeswax, Benzyl Alcohol, Bisabolol, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Echinacea Purpurea Extract, Geranium Maculatum Extract, Gluconolactone, Glycerin, Glyceryl Isostearate, Glyceryl Stearate, Glyceryl Stearate SE, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxyethylcellulose, Kaolin, PEG-100 Stearate, Phenoxyethanol, Polyhydroxystearic Acid, Polysorbate 60, Ricinus Communis (Castor) Seed Oil, Squalane, Tocopheryl Acetate, Water (Aqua).

Questions, Comments?

■ Questions, Comments: 1-844-WFM-TALK (1-844-936-8255)

Packaging Label Principal Display Panel

WF Diaper Cream Tube Front
(click image for full-size original)

BABYDIAPERCREAM
baby diaper cream cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42681-0032
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 14 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER 37 g in 100 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42681-0032-1 114 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/01/2022
Labeler — Whole Foods Market (196175616)
Registrant — Naturich Cosmetique Labs (124281663)

Revised: 02/2022 Whole Foods Market

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