Active Ingredient
DL-Camphor 1.2%
L-Menthol 5.7%
Methyl Salicylate 6.3%
Pain Relief Patch
FDA Label NDC 67510-0305
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kareway Product, Inc. for the product Pain Relief (NDC 67510-0305). 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 active ingredient, purpose, uses, warnings, do not use, ask a doctor before use,, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Topical Analgesic
Topical Analgesic
Uses
For temporary relief of minor aches and pains of muscles and joints associated with:
- arthritis
- simple backaches
- strains
- bruises
- sprains
Warnings
for external use only
Do Not Use
- on wounds or damaged skin
- if you are allergic to aspirin or salicylates
- with a heating pad
- with, or at the same time as, other external analgesic products
Ask A Doctor Before Use,
if you are allergic to any ingredients of this product.
When Using This Product
- use only as directed
- avoid contact with eyes, mucous membranes or rashes
Stop Use And Ask A Doctor If
- rash, itching or excessive skin irritation develops
- conditions worsen
- symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
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 to 4 times daily for 7 days
- wear up to 8 hours per application
- consult a doctor
Children under 12 years of age:
Other Information
- avoid storing product in direct sunlight
- protect from excessive moisture
Inactive Ingredients
butylated hydroxytoluene, glyceryl rosinate, natural rubber, polybutene, polyisobutylene, precipitated calcium carbonate, quintone, sorbitan stearate, tocopherol acetate, ys resin, zinc oxide
Carton Label
Pain Relief Patch
Image Of Carton Label (20patch.carton)
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