FDA Label for Pain Relief Medicated
View Indications, Usage & Precautions
Pain Relief Medicated Product Label
The following document was submitted to the FDA by the labeler of this product Rite Aid Corporation. 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.
Active Ingredient
| Active Ingredient | Purpose |
| Camphor 3.1% | Topical Analgesic |
| Menthol 6.0% | Topical Analgesic |
| Methyl Salicylate 10.0% | Topical Analgesic |
Inactive Ingredient
hydrogenated poly, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, styrene/isoprene copolymer
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.
Indications & Usage
For temporary relief of minor aches and pains of muscles and joins: arthritis, simple backache, muscle strains, muscle sprains and bruises.
Warnings
For External Use Only
Allergy Alert:If prone to allergic reactions from aspirine or salicytates, consult a doctor before use.
Dosage & Administration
Adults and children 12 years of age and over:
Clean and dry affected area. Remove patch from film, apply to affected area not more than 3-4 times a day.
Do not use for more than 8 hours.
Discard patch after use.
Reseal pouch after opening.
Children under 12 years of age, consult a physician.
If Pregnant Or Breastfeeding
ask a health professional before use.
Purpose
Topical Analgesic
When Using This Product:
■ Use only as directed ■ Avoid contact with eyes, mucous membranes or rashes ■ Do not bandage tightly ■ Do not use at the same time as other topical analgesics ■ Dispose of used patch away from children and pets. Used patches still contain the drug product which can produce serious adverse effects if a child or pet chews or ingests the patch.
Do Not Use
- On wounds or damaged skin
- With a heating pad
- If you are allergic to any ingredients in this product.
Stop Use And Consult A Doctor
- If rash, itching or excessive skin irritation develops
- If condition worsens
- If symptoms last more than 7 days or clear up and occur again in a few days.
Storage And Care
Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.
Pain Relieving Path
DIST. BY
RITE AID Co.
30 Hunter Lane
Camp Hill, PA 17011
www.riteaid.com
TOLL-FREE CUSTOMER CARE HELP LINE Mon–Fri, 8:30 am–4:30 pm CST 866-326-1313
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