MADE OF DIAPER RASH CREAM- zinc oxide cream

made of Diaper Rash Cream by

Drug Labeling and Warnings

made of Diaper Rash Cream by is a Otc medication manufactured, distributed, or labeled by MADEOF, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

USP Zinc Oxide 14%

Purpose

Skin Protectant

Uses

• Helps prevent and treat diaper rash
• Protects chafed skin due to diaper rash
• Helps seal out wetness

Warnings

For external use only

When using this product

avoid contact with eyes.

Stop use and ask a doctor if

condition worsens, symptoms last more than 7 days or clear up and return again within a few days.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

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

Ingredients

1Helianthus Annus* (Sunflower) Seed Oil, Cera Alba* (Beeswax), Cocos Nucifera* (Coconut) Oil, Olea Europaea' (Olive) Fruit Oil, Simmondsia Chinensis* (Jojoba) Oil, Butyrospermum Parkii* (Shea) Butter, Lavendula Angustilolia* (Lavender) Oil, Persea Grattisima*(Avocado) Oil, Argania Spinosa* (Argan) Oil, Tocopherol*

.

1 = Certified Organic

PRINCIPAL DISPLAY PANEL - 100.55 ml Box and Tube Label

made of ®

Diaper Rash Cream

85% Certified Organic Ingredients

15% Natural

NSF
EWG VERIFIED
Non GMO

Nut Free

Soy Free

Dermatologist Tested

Pediatrician Tested

3.4 fl.oz (100.55ml)

INGREDIENTS AND APPEARANCE

MADE OF DIAPER RASH CREAM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71439-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
YELLOW WAX (UNII: 2ZA36H0S2V)
TOCOPHEROL (UNII: R0ZB2556P8)
LAVENDER OIL (UNII: ZBP1YXW0H8)
SHEA BUTTER (UNII: K49155WL9Y)
AVOCADO OIL (UNII: 6VNO72PFC1)
ARGAN OIL (UNII: 4V59G5UW9X)
OLIVE OIL (UNII: 6UYK2W1W1E)
COCONUT OIL (UNII: Q9L0O73W7L)
JOJOBA OIL (UNII: 724GKU717M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71439-040-15	1 in 1 CARTON	09/05/2017
1		100.55 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 not final	part352	09/05/2017

Labeler - MADEOF, LLC (080635957)