BABY ANTI MONKEY BUTT DIAPER RASH- zinc oxide, calamine cream

BABY ANTI MONKEY BUTT DIAPER RASH by

Drug Labeling and Warnings

BABY ANTI MONKEY BUTT DIAPER RASH by is a Otc medication manufactured, distributed, or labeled by Denison Pharmaceuticals, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-8942
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Denison Pharmaceuticals, LLC. (001207208)

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