A And A Diaper Rash Cream
FDA Label NDC 55379-407

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Biozone Laboratories, Inc. for the product A And A Diaper Rash Cream (NDC 55379-407). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - purpose, uses, warnings, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

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

Otc - Keep Out Of Reach Of Children

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

A+A Diaper Rash Cream

with DIMETHICONE AND ZINC OXIDE

Helps treat and calm diaper rash

Allows Skin to heal naturally

A+a Diaper Rash Cream (Label Img)

A+a Diaper Rash Cream (Label Img)

A+A Diaper Rash Cream

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