MADE OF DIAPER RASH CREAM- zinc oxide cream 
MADEOF, LLC

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.

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made of ® Diaper Rash Cream

Drug Facts

Active Ingredient

USP Zinc Oxide 14%

Purpose

Skin Protectant

Uses

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

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)

Diaper Rash Tube

Diaper Rash box

MADE OF DIAPER RASH CREAM 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71439-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71439-040-151 in 1 CARTON09/05/2017
1100.55 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/05/2017
Labeler - MADEOF, LLC (080635957)

Revised: 1/2020
Document Id: 9c595e63-08c6-3358-e053-2995a90a54c4
Set id: 5876e61c-12d6-2313-e053-2a91aa0ab75a
Version: 2
Effective Time: 20200117
 
MADEOF, LLC