Otc - Active Ingredient
Menthol 16%
Pain Relief Liquid
FDA Label NDC 64092-402
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, Marking, And Sales, Inc. for the product Pain Relief Liquid (NDC 64092-402). 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 - pregnancy or breast feeding, otc - keep out of reach of children, instructions for use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical analgesic
Indications & Usage
temporariy relieves minor pain associated with:
- arthritis
- simple backache
- muscle strains
- sprains
- bruises
- cramps
Warnings
For external use only
When using this product
- use only as directed
- do not bandage tightly or use with a heating pad
- avoid contact with eyes and mucous membranes
- do not apply to wounds or damaged, broken or irritated skin
- a transient burning sensation may occur upon application but generally disappears in several days
- if severe burning sensation occurs, discontinue use immediately
- do not expose the area treated with product to heat or direct sunlight
- keep away from fire or flame
Flammable
Otc - Stop Use
stop use and ask a doctor if
- condition worsens
- redness is present
- irritation develops
- symptoms persist for more than 7 days or clear up and occur again witin a few days sy
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help, or contact a Poison control Center right away
Instructions For Use
Adults and children over 12 years;
- apply generously to affected area
- massage into painful area until thoroughly absorbed into skin
- repeat as necessary, but no more than 3-4 times daily
- IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER
children 12 years or younger: ask a doctor
Inactive Ingredient
acrylates/C10-30 alkyl acrylate crosspolymer, capsaicin, glycerin, isopropyl myristate, propylene glycol, SD alcohol 40 (3
0%), water (245-256)
Description
Personal Care Solutions
Maximum Strength
Pain Relief Liquid
with no mess roll-on applicator
Long lasting pain relief
- Powerful, fast acting formula
- Deep Penetrating Quick Drying
- Roller Ball Keeps Hands Clean
2.5 fl. oz. (73 ml)
Dosage & Administration
Adults and children over 12 years
- apply generously to affected area
- massage into painful area until thoroughly absorbed int skin
- repeat as necessary, but no more than 3-4 times daily.
* Please review the disclaimer below.
