Baby Anti Monkey Butt Diaper Rash (Zinc Oxide, Calamine) Cream [Denison Pharmaceuticals, Llc.] -

BABY ANTI MONKEY BUTT DIAPER RASH (ZINC OXIDE, CALAMINE) CREAM [DENISON PHARMACEUTICALS, LLC.]
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NDC	0295-8942-46
Set ID	e581d0c8-113e-43f4-9ffa-ad804544fb4f
Category	HUMAN OTC DRUG LABEL
Packager	Denison Pharmaceuticals, LLC.
Generic Name
Product Class
Product Number
Application Number	PART348

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Active Ingredients

Zinc Oxide 12.0%, Calamine Powder 2.0%
Purpose

Skin Protectant
Uses
- helps treat and prevent diaper rash
- protects chafed skin due to diaper rash and helps seal out wetness
Warnings

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
Keep out of reach of children

If swallowed, get medical help or contact Poison Control Center right away.
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 may be prolonged
Other information
- store at 20° to 27°C (68° to 80°F)
Inactive ingredients

allantoin, calendula extract, castor oil, dowicil, mineral oil, Peruvian balsam, white petrolatum
Questions?

Call 1-844-426-8465
BABY ANTI MONKEY BUTT DIAPER RASH (ZINC OXIDE, CALAMINE) CREAM

INGREDIENTS AND APPEARANCE

BABY ANTI MONKEY BUTT DIAPER RASH
zinc oxide, calamine cream

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.12 g in 1 g
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)	FERRIC OXIDE RED	0.02 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
Allantoin (UNII: 344S277G0Z)
Calendula Officinalis Seed Oil (UNII: 9JS8DS42SV)
Castor Oil (UNII: D5340Y2I9G)
Mineral Oil (UNII: T5L8T28FGP)
Balsam Peru (UNII: 8P5F881OCY)
Petrolatum (UNII: 4T6H12BN9U)
Calendula Officinalis Flower (UNII: P0M7O4Y7YD)
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0295-8942-46	85 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	01/01/2017

Labeler - Denison Pharmaceuticals, LLC. (001207208)

Name	Address	ID/FEI	Business Operations
Establishment
Denison Pharmaceuticals, LLC.		001207208	manufacture(0295-8942)

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