DENINO DIAPER RASH - rash prevention cream cream
Corpsain SA de CV

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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Diaper Rash Cream. Drug Facts

Drug Facts

Quickly eliminates redness and Rash thanks to its unique combination of calendula, chamomile and oat extracts.

Directions for use

Directions for use: Apply a thick layer to the affected area on each diaper change, after cleansing and drying skin completely.

Warnings: Do not apply to an open wound. Stop use and ask doctor if irritation or rash persists.

Zinc oxide, Avena Sativa Flowering Top, Medium-Chain Triglycerides, Lanolin, Matricaria Recutita, Allantoin, Calendula Officinalis Flower.

Other Ingredients: Petrolatum, Yellow Wax, Sorbitan Monostereate, Glycerlyl Monostearate, Stearyl Alcohol, Butylated Hydroxytoluene.

Made in Mexico by Corpsain SA de CV.

www.corpsain.com sales@corpsain.com

Phone +(52) 81 83 46 5800

Imported and Distributed by Montdani International LCC. info@Montdani.com

Phone (830) 626 0468

DENINO DIAPER RASH
rash prevention cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50760-8051
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.8 mL in 60 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	.6 mL in 60 mL
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) (MEDIUM-CHAIN TRIGLYCERIDES - UNII:C9H2L21V7U)	MEDIUM-CHAIN TRIGLYCERIDES	18.21 mL in 60 mL
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	2.4 mL in 60 mL

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
WAX, YELLOW (UNII: 2ZA36H0S2V)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50760-8051-6	60 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	04/01/2010

Labeler - Corpsain SA de CV (814593448)

Name	Address	ID/FEI	Business Operations
Establishment
Corpsain SA de CV		814593448	manufacture, label