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Drug Facts
Astonea Care Muscle And Join Pain Relief Cream
FDA Label NDC 77338-212
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 Astonea Care Muscle And Join Pain Relief Cream (NDC 77338-212). 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 other, otc - active ingredient, otc - purpose, uses, warnings, do not use, otc - ask doctor, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Menthol 10%
Methyl salicylate 15%
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| Menthol 10% | Topical analgesic |
| Methyl salicylate 15% | Topical analgesic |
Uses
temporarily relieves the minor aches and pains of muscles and joints associated with:
- simple backache
- arthritis
- strains
- bruises
- sprains
Warnings
For external use only.
Do Not Use
- on wounds or damaged skin
- with a heating pad
- on a child under 12 years of age with arthritis-like conditions
Otc - Ask Doctor
Ask a doctor before use if you haveredness over the affected area
When Using This Product
- avoid contact with eyes or mucous membranes
- do not bandage tightly
Stop Use And Ask A Doctor If
- excessive skin irritation occurs
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days
Otc - 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. (1-800-222-1222)
Directions
- use only as directed
- adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily
- children under 12 years of age: consult a physician.
Other Information
store at 20° to 25°C (68° to 77°F)
do not use if tube seal under cap is broken
Inactive Ingredients
borax, butylated hydroxytoluene, carbopol 940, cetostearyl alcohol, cetyl alcohol, glycerol monostearate, peg 100 stearate, phenoxyethanol, sodium benzoate, stearic acid, trolamine, tween 60, water
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