FDA Label for Balmex Adult Care Rash

View Indications, Usage & Precautions

Balmex Adult Care Rash Product Label

The following document was submitted to the FDA by the labeler of this product Randob Labs,ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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)


* Please review the disclaimer below.