Active Ingredients
Menthol 0.44% w/w
Zinc Oxide 20.625% w/w
Menthol And Zinc Oxide
FDA Label NDC 77338-013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Astonea Labs Private Limited for the product Menthol And Zinc Oxide (NDC 77338-013). 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 active ingredients, purpose, uses, warnings:, stop use and ask a doctor if, keep out of reach of children, dosage & administration:, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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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