BAMBOOBIES DIAPER RASH- zinc oxide 15% spray 
Derma Care Research Labs, 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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Zinc Oxide 15%

Skin Protectant

Helps treat and prevent diaper rash, protects chafed skin due to diaper rash.

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.

If swallowed, get medical help or contact a Poison Control Center right away.

Change wet and soiled diapers promptly. Cleanse the diaper area. Allow to dry. Shake well before each use. Spray liberally onto affected area with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged. Apply as needed.

Aloe Barbadensis Leaf Juice, Bentonite, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis flower Extract, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, chamomilla Recutita (Matricaria) Flower Extract, Coco-Glucoside, Glycerin, Glyceryl Oleate, Glyceryl Rosinate, Helianthus Annuus (Sunflower) Seed Oil, Microcrystalline Cellulose, Olea Europaea (Olive) Fruit Oil, Olea Europaes 9Olive) Oil Unsaponifiables, Propanediol, Ricinus Communis (Castor) Seed Oil, Water.

Carton

BAMBOOBIES DIAPER RASH 
zinc oxide 15% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-132
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SHEA BUTTER (UNII: K49155WL9Y)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL OLEATE (UNII: 4PC054V79P)  
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
PROPANEDIOL (UNII: 5965N8W85T)  
BENTONITE (UNII: A3N5ZCN45C)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
GLYCERYL ROSINATE (UNII: SD112V492J)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCO GLUCOSIDE (UNII: ICS790225B)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CHAMOMILE (UNII: FGL3685T2X)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
CASTOR OIL (UNII: D5340Y2I9G)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72839-132-03100.5 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/09/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01603/09/2023
Labeler - Derma Care Research Labs, LLC (116817470)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs, LLC116817470manufacture(72839-132)

Revised: 8/2023
Document Id: 0411f5e3-03d3-c512-e063-6394a90a37d3
Set id: 0411f5e3-03d2-c512-e063-6394a90a37d3
Version: 1
Effective Time: 20230829
 
Derma Care Research Labs, LLC