Balmex Adult Care Rash Cream
FDA Label NDC 52412-500

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 Adult Care Rash (NDC 52412-500). 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, 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

Distributed by RANDOB LABS LTD.
Box 440, Cornwall, NY 12518

Otc - Purpose

Active Ingredients                                     Purpose
Zinc Oxide 11.3%Skin protectant

Uses

  • helps relieve and prevent rashes and irritation due to wetness from incontinence
  • protects chafed skin due to irritation and helps seal out wetness

Warnings

For external use only

When Using This Product

  • avoid contact with eyes

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms persist 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 immediately.

Directions

  • gently cleanse affected skin
  • pat dry with a clean, soft cloth or allow to air dry
  • apply generously to affected area as needed, especially after incontinence episodes
  • using a dry tissue to remove excess product from skin is most effective

Inactive Ingredient

Inactive ingredients mineral oil, water, beeswax, microcrystalline wax, synthetic beeswax, fragrance, sorbitan sesquioleate, oenothera biennis (evening primrose) seed extract, olea europaea (olive) leaf extract, dimethicone, tocopherol, methylparaben, glycine soja (soybean) oil, propylparaben, panthenol, sarcosine, benzoic acid, potassium aspartate, potassium hydroxide, magnesium aspartate, sodium cocoyl amino acids (309-021) 

Otc - Questions

For more information please visit 
www.BalmexAdult.com

Principal Display Panel - 85 G Tube Carton

Activ
Guard™

NEUTRALIZES
IRRITANTS

Balmex®
ADULTCARE™

RASH CREAM
ZINC OXIDE 11.3%

Soothes &
Protects Skin
From Irritation, Chafing & Rash

Dermatologist Tested
Works in One Use*
Odor-Free

NET WT 3 OZ (85 g)

Principal Display Panel (85 g Tube Carton)

Principal Display Panel (85 g Tube Carton)

* Please review the disclaimer below.