FDA Label for Menthol And Zinc Oxide
View Indications, Usage & Precautions
Menthol And Zinc Oxide Product Label
The following document was submitted to the FDA by the labeler of this product Astonea Labs Private Limited. 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.
Active Ingredients
Menthol 0.44% w/w
Zinc Oxide 20.625% w/w
Purpose
Menthol 0.44% w/w…………….……External Analgesic
Zinc Oxide 20.625% w/w………………. Skin Protectant
Uses
A moisture barrier that prevents and helps heal skin irritations from;
- urine
- diarrhea
- perspiration
- fistula drainage
- feeding tube site leakage
- wound drainage (peri-wound skin)
- minor burns
- cuts
- scrapes
- itching
Warnings:
■For external use only ■Not for deep or puncture wounds ■Avoid contact with 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
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.
Dosage & Administration:
- Clean skin with mild skin cleanser
- Pat dry or allow to air dry
- Apply a thin layer of Calasoothe to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection
Inactive Ingredients
Calamine, Glycerine, Lanolin, Light Liquid Paraffin, Petrolatum, Thymol, Tocopheryl Acetate
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