FDA Label for Balmex Diaper Rash
View Indications, Usage & Precautions
Balmex Diaper 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.
Otc - Active Ingredient
Zinc Oxide 11.3%
Otc - Purpose
Skin Protectant
Indications & Usage
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
If swallowed, seek medical help or contact a Poison Control Center immediately.
Dosage & Administration
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.
Inactive Ingredient
Beeswax, benzoic acid, dimethicone, glycine soja (soybean) oil, magnesium aspartate, microcrystalline wax, mineral oil, oenothera biennis (evening primrose) seed extract, olea europae (olive) leaf extract, panthenol, Peruvian balsam, Phenoxyethanol, potassium aspartate, potassium hydroxide, sarcosine, sodium cocoyl amino acids, sorbitan sesquioleate, synthetic beeswax, tocopherol, water.
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