ZOEY NATURALS DIAPER CREAM- zinc oxide cream

ZOEY NATURALS DIAPER Cream by

Drug Labeling and Warnings

ZOEY NATURALS DIAPER Cream by is a Otc medication manufactured, distributed, or labeled by Absolutely Natural. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Zinc Oxide 15%

Purpose

Skin Protectant

Uses

ZOEY Naturals DIAPER CREAM helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness.

Warnings

For external use only.

When using this product

do not get into eyes.

rinse with water to remove.

Stop use and ask doctor if condition worsens  rash or irritation develops and lasts more than 7 days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Change wet and soiled diapers promptly, cleanse diaper area and allow to dry Apply cream liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Other information

Will stain clothing

Store at room temperature

Inactive ingredients

(INCI): Cocoa nucifera (coconut) oil, butyrospermum parkii (shea) butter, helianthus annuus (sunflower) seed oil, cera alba (beeswax), ricinus communis (castor) seed oil, carthamus tinctorius (safflower) seed oil, vitis vinifera (grape) seed oil, maranta arundinacea (arrowroot) root powder, theobroma cacao (cocoa) seed butter, mangifera indica (mango) seed butter, persea gratissima (avocado) oil, kaolin clay, tocopheryl acetate (vitamin E).

Questions?

Call us! 800-848-8498

SPL UNCLASSIFIED SECTION

Fragrance Free

SKIN PROTECTANT

HYPOALLERGENIC, NO HARSH CHEMICALS, THERAPEUTIC RELIEF, ZINC BLEND

made for babies

loved by mamas

www.Zoey-Naturals.com

Manufactured by: Absolutely Natural, Inc.

640 Atlantis Road, Melbourne, FL 32904

Packaging

INGREDIENTS AND APPEARANCE

ZOEY NATURALS DIAPER CREAM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70793-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	15 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)
SHEA BUTTER (UNII: K49155WL9Y)
SUNFLOWER OIL (UNII: 3W1JG795YI)
WHITE WAX (UNII: 7G1J5DA97F)
CASTOR OIL (UNII: D5340Y2I9G)
SAFFLOWER OIL (UNII: 65UEH262IS)
GRAPE SEED OIL (UNII: 930MLC8XGG)
MARANTA ARUNDINACEA ROOT (UNII: FVN346W31A)
COCOA BUTTER (UNII: 512OYT1CRR)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
AVOCADO OIL (UNII: 6VNO72PFC1)
KAOLIN (UNII: 24H4NWX5CO)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70793-010-34	1 in 1 BOX	03/09/2020
1		100 mL 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	03/09/2020

Labeler - Absolutely Natural (166425202)

Establishment
Name	Address	ID/FEI	Business Operations
Absolutely Natural		166425202	manufacture(70793-010)