FDA Label for Astonea Cold Therapy
View Indications, Usage & Precautions
Astonea Cold Therapy 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.
Otc - Active Ingredient
Menthol 4%
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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