Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID e4424d74-f89c-5943-42e8-bf3a38e68619
Route
TOPICAL
Published
Effective Date 2015-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (0.12 g) Ferric Oxide Red (0.02 g)
Inactive Ingredients
Allantoin Calendula Officinalis Seed Oil Castor Oil Mineral Oil Balsam Peru Petrolatum Calendula Officinalis Flower Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-03-01

Description

Zinc Oxide 12.0%, Calamine Powder 2.0%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Zinc Oxide 12.0%, Calamine Powder 2.0%

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

For external use only

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
Questions?

Call 1-844-426-8465

Other Information
  • store at 20° to 27°C (68° to 80°F)
Active Ingredients

Zinc Oxide 12.0%, Calamine Powder 2.0%

Inactive Ingredients

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

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

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.


Structured Label Content

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
Purpose

Skin Protectant

Warnings

For external use only

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
Questions?

Call 1-844-426-8465

Other Information (Other information)
  • store at 20° to 27°C (68° to 80°F)
Active Ingredients

Zinc Oxide 12.0%, Calamine Powder 2.0%

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (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

When Using This Product (When using this product)
  • do not get into eyes
Stop Use and Ask A Doctor If (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 (Keep out of reach of children)

If swallowed, get medical help or contact Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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