Baby anti monkey butt diaper rash powder

Spl unclassified section

Drug Facts

active ingredientsactive ingredients

Calamine Powder 8.0%

purposepurpose

Skin Protectant

usesuses

  • Helps treat and prevent diaper rash
  • Protects chafed skin and minor skin irritations due to diaper rash
  • Helps protect from wetness

warningswarnings

For external use only

when using this productwhen using this product

  • Avoid contact with eyes
  • Do not use on broken skin
  • Keep powder away from childs face to avoid inhalation, which can cause breathing problems

stop use and ask a doctor ifstop use and ask a doctor if

  • Condition worsens
  • Symptoms do not get better within 7 days

keep out of reach of children.keep out of reach of children.

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

directionsdirections

  • 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 diaper may be prolonged. Apply powder close to the body away from the childs face. Carefully shake the powder into the diaper or into the hand and apply to the diaper area.

inactive ingredientsinactive ingredients

Cornstarch, fragrance, tricalciumphosphate

Ingredients and appearance - Product information

Baby anti monkey butt diaper rash powder- Ferric oxide red and zinc oxide

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 42364-0013
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Zinc oxide ( UNII: SOI2LOH54Z)( Zinc oxide - UNII: SOI2LOH54Z ) 0.076 gin 1 g
Ferric oxide red ( UNII: 1K09F3G675)( Ferric oxide red - UNII: 1K09F3G675 ) 0.004 gin 1 g

Inactive Ingredients

Ingredient Name Code
Starch, corn ( UNII: O8232NY3SJ)
Tricalcium phosphate ( UNII: K4C08XP666)

Product Characteristics

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 42364-0013-0 170g in 1 BOTTLE 2012/04/18

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part347 USA 2012/04/18

Labeler - DSE Healthcare Solutions, LLC.( 603016069)

Establishment

Name ID/FEI Business Operations
DSE Healthcare Solutions, LLC. 603016069 MANUFACTURE( 42364-0013)

principal display panelprincipal display panel

Tender Loving Care for
Your Babys Derrire
Helps Prevent & Treat
Diaper RashChafing
Minor Skin Irritations
Helps Protect from Wetness
Baby
Anti Monkey
Butt®
Diaper Rash Powder
with Calamine
Helps Treat and Prevent Diaper Rash
NET WT 6oz (170g)