OTC Medication Information: A and D

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.

Drug Facts

Dimethicone, Zinc Oxide

Active ingredients Purpose
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

New Look

A+D ®

Treat

Diaper Rash Cream

with Dimethicone and Zinc Oxide

  • Works on contact to help treat & calm diaper rash
  • Allows skin to heal naturally

PEDIATRICIAN RECOMMENDED

PARABEN-FREE

DYE-FREE

MOISTURIZING WITH ALOE

NET WT

1.5 OZ (42.5 G)

Carton 1.5 oz.
(click image for full-size original)
A AND D
dimethicone and zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-1314
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 11.09 mg in 1 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 110.09 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA FLOWER
BENZYL ALCOHOL
COCONUT OIL
COD LIVER OIL
LIGHT MINERAL OIL
PARAFFIN
PROPYLENE GLYCOL
SORBITOL
WATER
Product Characteristics
Color white (White cream) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11523-1314-2 1 TUBE in 1 CARTON contains a TUBE
1 113 g in 1 TUBE This package is contained within the CARTON (11523-1314-2)
2 NDC:11523-1314-3 1 TUBE in 1 CARTON contains a TUBE
2 85 g in 1 TUBE This package is contained within the CARTON (11523-1314-3)
3 NDC:11523-1314-1 1 TUBE in 1 CARTON contains a TUBE
3 42.5 g in 1 TUBE This package is contained within the CARTON (11523-1314-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 12/25/2009
Labeler — Bayer HealthCare LLC. (112117283)

Revised: 10/2020 Bayer HealthCare LLC.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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