BABY DIAPER RASH CREAM- baby diaper rash cream cream 
Royal Labs Natural Cosmetics, 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.

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Deep Steep Baby Diaper Rash Cream

Drug Facts

Active Ingredient....Zinc Oxide 25%

Purpose....Skin Protectant

Warnings

For External Use Only

When using this product

Do not get into eyes

Stop use and ask a doctor

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 reach of children

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

Purpose

Skin Protectant

Directions

Change wet and soiled diapers promptly

Cleanse 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 diapers may be prolonged.

Uses

Helps treat and prevent diaper rash

Protects chafed skin due to diaper rash and helps seal out wetness

Inactive Ingredients

Organic Helianthus Annuus (Sunflower) Seed Oil, Organic Calendula Officinalis Flower Oil, Hydrogenated Vegetable Oil, Organic Cocos Nucifera (Coconut) Oil, Organic Decolorized Aloe Barbadensis Leaf Oil, Euphorbia Cerifera (Candelilla) Wax, Organic Rosmarinus Officinalis (Rosemary) Leaf Extract, Organic Ocicum Basilicum (Basil) Leaf Extract, Lecithin

Deep Steep Baby Diaper Rash Cream

Deep Steep Baby Diaper Rash Cream

Diaper Cream JPEG.jpg

Diaper Cream JPEG.jpg

BABY DIAPER RASH CREAM 
baby diaper rash cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69580-600
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CORN OIL (UNII: 8470G57WFM)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CANDELILLA WAX (UNII: WL0328HX19)  
ROSEMARY (UNII: IJ67X351P9)  
BASIL OIL (UNII: Z129UMU8LE)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
COCONUT OIL (UNII: Q9L0O73W7L)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69580-600-02114 g in 1 TUBE; Type 0: Not a Combination Product08/11/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/11/201611/07/2017
Labeler - Royal Labs Natural Cosmetics, Inc (197478480)
Establishment
NameAddressID/FEIBusiness Operations
Royal Labs Natural Cosmetics, Inc197478480label(69580-600) , manufacture(69580-600)

Revised: 11/2017
 
Royal Labs Natural Cosmetics, Inc