Otc - Active Ingredient
Menthol 4%
Astonea Cold Therapy
FDA Label NDC 77338-007
10 label sections · Submitted to the FDA by Astonea Labs Private Limited · 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 Astonea Cold Therapy (NDC 77338-007). 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, indications & usage, warnings, otc - ask doctor, otc - when using, 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
Topical Analgesic
Indications & Usage
Temporary relief from minor aches and pains of sore muscles and joints associated with:
arthritis
backache
strains
sprains
Warnings
For external use only
Flammable:Keep away from excessive heat or open flame
Otc - Ask Doctor
Ask a doctor before use if you have: sensitive skin
Stop use and ask a doctor if
condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.
Otc - When Using
When using this product
■avoid contact with eyes or mucous membranes ■do not apply to wounds or damaged skin ■ do not use with other ointments, creams, sprays or liniments ■ do not apply to irritated skin or if excessive irritation develops ■do not bandage ■ wash hands alter use with cool water ■do not use with heating pad or device
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children: If accidentally ingested, get medical help or contact a poison Control immediately (1800-222-1222)
Dosage & Administration
Directions
Adults and children 2 years of age and older:Rub a thin film over affected areas not more than daily: massage not necessary
Children under 2 years of age :Consult physician
Inactive Ingredient
camphor, carbopol 940, DMDM hydantoin, edetate disodium, FD&C yellow no. 5, FD&C blue no. 1, isopropyl alcohol, PEG 40
hydrogenated castor oil, propylene glycol, sodium hydroxide, water
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