Balmex Diaper Rash Cream
FDA Label NDC 52412-400

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Randob Labs,ltd. for the product Balmex Diaper Rash (NDC 52412-400). 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 other, otc - purpose, uses, warnings, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredients Purpose
Zinc Oxide 11.3%Skin protectant

Uses

  • Helps treat and prevent diaper rash
  • protects chafed skin 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 immediately.

Directions

  • change wet or 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 any time when exposure to wet diapers may be prolonged

Other Information

  • do not use if quality seal is broken
  • see bottom of carton and or top of tube for lot number and expiration date

Inactive Ingredient

Inactive ingredients Beeswax, benzoic acid, dimethicone, fragrance, glycine soja (soybean) oil, magnesium aspartate, methylparaben, microcrystalline wax, mineral oil, oenothera biennis (evening primrose) seed extract, olea europea (olive) leaf extract, panthenol, potassium aspartate, potassium hydroxide, propylparaben, sarcosine, sodium cocoyl amino acids, sorbitan sesquioleate, synthetic beeswax, tocopherol, water (245-230)

Questions?

1-833-389-9450

Dist. by: RANDOB LABS LTD. Box 440, Cornwall, NY 12518

Principal Display Panel - 113 G Tube Carton

NEW LOOK-SAME PRODUCT

Balmex®
COMPLETE
PROTECTION™

Zinc Oxide

DIAPER RASH CREAM

Prevents & Heals

  • ✔Protects against
    all 3 leading causes
    of diaper rash
  • ✔Reduces rash in
    just 1 diaper change

    • Pediatrician Recommended

    Advanced
    Formula

    NET WT 4 OZ (113 g)

    Principal Display Panel (113 g Tube Carton)

    Principal Display Panel (113 g Tube Carton)

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