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 Clarion Brands, 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

PRINCIPAL DISPLAY PANEL

Fragrance-Free

Baby Anti Monkey Butt®
Diaper Rash Cream
with Calamine

Helps Treat and Prevent Diaper Rash

NET WT 3 oz (85 g)

Tender Loving Care for Your Baby's Derrière

Helps Prevent & Treat
Diaper Rash Chafing Minor Skin Irritations

Helps Protect from Wetness

For Products and Information:
www.antimonkeybutt.com


Distributed by: Clarion Brands, LLC
27070 Miles Road, Suite A, Solon, OH 44139
8942A    ©2015

Baby Anti Monkey Butt®
AML3000025C

INGREDIENTS AND APPEARANCE

BABY ANTI MONKEY BUTT DIAPER RASH  
zinc oxide, calamine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69693-818
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: 69693-818-03	85 g in 1 TUBE; Type 0: Not a Combination Product	03/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/01/2016

Labeler - Clarion Brands, LLC (079742703)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC		001207208	manufacture(69693-818)