Otc - Active Ingredient
Menthol 16.0%
Pain Relief Sleeve
FDA Label NDC 64092-520
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Great Lakes Wholesale, Marketing, And Sales, Inc for the product Pain Relief Sleeve (NDC 64092-520). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, instructions for use, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analgesic Patch
Indications & Usage
For temporary relief of minor aches and pains of muscles and joints associated with:
- arthritis
- strains
- bruises
- sprains
Warnings
For external use only
When using this product:
- avoid contact with eyes
- do not apply to wounds or damaged skin
- do not bandage tightly
- do not use with heating pad
Otc - Stop Use
Stop using and ask a doctor
if redness is present or irritation develops. Condition worsens, or if symptioms persist for more than 7 days or clear up and occur again within a few days.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately
Instructions For Use
- Adults and children over 12 years: pull sleeve onto knee or large ankles or elbows until the colored section of the sleeve is positioned directly over the affected area. Sleeve should feel snug, but not tight.
- Children 12 years or younger: consult a doctor
Inactive Ingredient
diethylene glycol monoethyl ether acetate, cetanol, glycerol, glycerol monostearate, methylparaben, 2(2-aminoethoxy) ethanol, sorbitan sesquiolate, sodium polyacrylate, polysorbate 80, aloe barbadensis leaf extract, methyl orange-xylene cyanol solution, ethylenediaminetetracetic acid tetrasodium salt hydrate.
Description
NDC 64092-506-1, ITEM 863906
GLS
Personal Care Solutions
Extra Strength
Menthol 16%
Pain Relief Sleeve
KNEE & Small-Medium ankles & elbows
Medicated Sleeve
Pain relieving Lotion on a Breathable Sleeve
Medium
Ideal for KNEE
EXPANDS TO FIT 5" TO 12" (12.5cm to 30.5cm)
IN CIRCUMFERENCE
Contains 1 Sleeve Patch
KNEE
- ELBOT
- ANKLE
- WRIST
- ELBOW
- ANKLE
- WRIST
NDC 64092-520-1, ITEM 863920
GLS
Personal Care Solutions
Extra Strength
Menthol 16%
Pain Relief Sleeve
KNEE & Large Ankles & Elbows
Medicated Sleeve
Pain relieving Lotion on a Breathable Sleeve
Large Sleeve
Ideal for KNEE
EXPANDS TO FIT 8" TO 24" (20 CM TO 61 CM)
IN CIRCUMFERENCE
Contains 1 Sleeve Patch
KNEE
NDC 64092-520-1, ITEM 863920
GLS
Personal Care Solutions
Extra Strength
Menthol 16%
Pain Relief Sleeve
KNEE & Large Ankles & Elbows
Medicated Sleeve
Pain relieving Lotion on a Breathable Sleeve
XLarge Sleeve
Ideal for KNEE
EXPANDS TO FIT 12" TO 28" (30.5 CM to 70 CM)
IN CIRCUMFERENCE
Contains 1 Sleeve Patch
KNEE
ELBOW
ANKLE
WRIST
Dosage & Administration
Adults and children over 12 years: pull sleeve onto knee or large ankle or elbow until the colored section of the sleeve is positioned directly over the affected area. sleeve should feel snug, but not tight.
* Please review the disclaimer below.
