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Drug Facts
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
Walgreens Pain Relieving Cream
FDA Label NDC 0363-1199
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Walgreens Pain Relieving (NDC 0363-1199). 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 - purpose, uses, warnings, do not use, otc - pregnancy or breast feeding, when using this product, stop use and consult a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| Camphor 4% | Topical Analgesic |
| Menthol 10.0% | Topical Analgesic |
| Methyl Salicylate 30% | Topical Analgesic |
Uses
for the temporary relief of minor aches and muscles and joints associated with
♦ arthritis♦ simple backache♦ strains♦ sprains
Warnings
For external use only. ALLERGY ALERT if prone to allergic reaction from aspirin or salicylates, consult a doctor before use. Avoid contact with eyes and mucous membranes.
Do Not Use
♦ for arthritis-like conditions in children under 12. Consult a doctor.♦ with a heating pad♦ on wounds or damaged skin
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding ask a health professional before use
When Using This Product
♦ use only as directed♦ do not swallow♦ do not bandage tightly
Stop Use And Consult A Doctor If
♦ condition worsens or pain lasts for 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 (1-800-222-1222) right away.
Directions
♦ Adults and children 12 years of age and older: apply to affected area not more than 3 or 4 times daily. Children under 12 years of age: consult a doctor
Other Information
Store at room temperature
Inactive Ingredients
Carbomer, Disodium EDTA, Glyceryl Stearate SE, Lanolin, Polysorbate 80, Potassium Hydroxide, Stearic Acid, Triethanolamine, Water.
Questions Or Comments?
1-800-925-4733
Principal Display Panel - 113 G Tube Carton
Walgreens
Compare to Ultra Strength
BENGAY® active ingredients††
Pain
Relieving
Cream
CAMPHOR 4% / MENTHOL 10% /
METHYL SALICYLATE 30% /
TOPICAL ANALGESIC
ULTRA STRENGTH
NON-GREASY
- Relief from minor arthritis,
backache, muscle & joint pain
NET WT 4 OZ (113 g)
Principal Display Panel (113 g Tube Carton)
* Please review the disclaimer below.
