Otc - Active Ingredient
Camphor 1%
Natureance Body Balm Liquid
FDA Label NDC 80465-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Eros Global Corp for the product Natureance Body Balm (NDC 80465-100). 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 otc - active ingredient, otc - purpose, use, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
External Analgesic
Use
For the temporary relief of pain.
Warnings
For external use only. · Ask a doctor before use if you have redness over affected area.
Otc - When Using
Avoid contact with eyes.
Use only as directed.
Do not apply to wounds or damaged, broken, or irritated skin.
Do not bandage tightly or use with a heating pad
If you experience an allergic reaction, discontinue use, and consult a physician.
Otc - Stop Use
Condition worsens.
Redness is present.
Irritation develops.
Symptoms persist for more than 7 days or clear up occur again within a few days.
You experience signs injury, such as pain, swelling or blistering where the product was applied.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast – feeding
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help, or contact a Poison Control Center right away.
Directions
Adults and Children over 12 years
Apply to affected area not more than three to four times daily.
Children under 12 years of age: do not use, consult a doctor.
Other Safety Information
Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).
Inactive Ingredient
Alcohol Denat, Water (Aqua), Glycerin, Polysorbate 20, Fragrance, Parfum, Arnica Montana Flower Extract, Cymbopogon Nardus (Citronella) Oil, FD&C Yellow No.5 (CI 19140), FD&C Blue No.1 (CI 42090), Benzyl Benzoate, Limonene, Benzyl Salicylate, Geraniol, Hexyl Cinnamal, Citral, Amyl Cinnamal, Citronellol, Linalool, Hydroxycitronellal, Eugenol, Farnesol.
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