BABY ANTI MONKEY BUTT DIAPER RASH- zinc oxide, ferric oxide red powder

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, Thornton Industries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Calamine Powder 8.0%

Purpose

Skin Protectant

Uses

• helps treat and prevent diaper rash
• protects chafed skin and minor skin irritations due to diaper rash
• helps protect from wetness

Warnings

For external use only

When using this product

• avoid contact with eyes
• do not use on broken skin
• keep powder away from child's face to avoid inhalation, which can cause breathing problems

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

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 2 years and older: apply freely up to 3 or 4 times daily. For best results, dry skin thoroughly before applying.
• babies: change wet and soiled diaper promptly, cleanse the diaper area and allow to dry. Apply powder liberally as often as necessary, with each diaper change, especially at bedtime, or anytime when exposure to wet diapers may be prolonged. Apply powder close to the body away from child's face. Carefully shake the powder into the diaper or into the hand and apply to the diaper area.

Inactive ingredients

cornstarch, fragrance, tricalciumphosphate

Questions?

Call 1-844-426-8465

PRINCIPAL DISPLAY PANEL

Baby Anti Monkey Butt®
Diaper Rash Powder
with Calamine

Talc Free!

Helps Treat and Prevent Diaper Rash

NET WT 6 oz (170 g)

Please recycle

Tender Loving Care for Your Baby's Derrière

Helps Prevent & Treat
Diaper Rash
Chafing
Minor Skin Irritations

Helps Protect from Wetness

Sold by weight not by volume.
Some settling will occur.

For Products and Information:
www.antimonkeybutt.com


Distributed by: Clarion Brands, LLC
27070 Miles Road, Suite A, Solon, OH 44139
AML2000025C    ©2015

Baby Anti Monkey Butt®
AML3000025C

INGREDIENTS AND APPEARANCE

BABY ANTI MONKEY BUTT DIAPER RASH  
zinc oxide, ferric oxide red powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69693-815
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.076 g  in 1 g
Ferric Oxide Red (UNII: 1K09F3G675) (Ferric Oxide Red - UNII:1K09F3G675)	Ferric Oxide Red	0.004 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Starch, Corn (UNII: O8232NY3SJ)
Tricalcium Phosphate (UNII: K4C08XP666)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69693-815-06	170 g in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2016

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

Labeler - Clarion Brands, LLC (079742703)

Establishment
Name	Address	ID/FEI	Business Operations
Thornton Industries, Inc.		614259299	MANUFACTURE(69693-815)