A+D Diaper Rash Cream

A+D Diaper Rash Cream

Drug Labeling and Warnings

Drug Details

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A AND D- dimethicone and zinc oxide cream 
Bayer HealthCare LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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A+D

Diaper Rash Cream

Drug Facts

Dimethicone, Zinc Oxide

Active ingredientsPurpose
Dimethicone 1%Diaper rash Cream
Zinc Oxide 10%Diaper rash Cream

Uses

  • helps treat and prevent diaper rash
  • protects minor skin irritation 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 a Poison Control Center right away.

Directions

  • change wet and soiled diapers promptly
  • cleanse the diaper area, and 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 between 20°C to 25 °C ( 68° to 77°F)

Inactive Ingredients

Aloe barbadensis extract, benzyl alcohol, coconut oil, cod liver oil ( contains vitamin A & Vitamin D), fragrance, glyceryl oleate, light mineral oil, ozokerite, paraffin, propylene glycol, sorbitol, synthetic beeswax, water

PRINCIPAL DISPLAY PANEL - 113g Carton

PEDIATRICIAN RECOMMENDED

A+D®

Treat

Diaper Rash Cream

WITH DIMETHICONE AND ZINC OXIDE

  • Helps treat & calm diaper rash
  • Allows skin to heal naturally

NET WT 4 OZ (113g)

moisturizing

with ALOE

4 oz carton

A AND D 
dimethicone and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11523-1314
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE11.09 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE110.09 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA FLOWER (UNII: 575DY8C1ER)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
COCONUT OIL (UNII: Q9L0O73W7L)  
COD LIVER OIL (UNII: BBL281NWFG)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorwhite (White cream) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11523-1314-21 in 1 CARTON12/25/2009
1113 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 11523-1314-31 in 1 CARTON12/25/2009
285 g in 1 TUBE; Type 0: Not a Combination Product
3NDC: 11523-1314-11 in 1 CARTON12/25/2009
342.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/25/2009
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 6/2017
 
Bayer HealthCare LLC.


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