Otc - Active Ingredient
Active Ingredient Purpose
Menthol 5%--------------------------------------------------------- Topical analgestic
Assured Cold N Hot Pain Relief Menthol
FDA Label NDC 33992-6159
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Greenbrier International, Inc for the product Assured Cold N Hot Pain Relief Menthol (NDC 33992-6159). 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, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
Temporarily relieves minor pains associated with:
- arthritis
- simple backache
- bursitis
- tendonitis
- muscle strains
- muscle cramps
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use
- on wounds or damaged skin
- with a heating pad
- on a child under 12 years of age with arthritis-like conditions
Otc - Ask Doctor
Ask a doctor before use if you have
- redness over the affected area
Otc - When Using
When using this product
- use as only directed
- avoid contact with eyes and mucous membranes
- do not bandage tightly
- discontinue use at least 1 hour before a bath or shower
- do not use immediately after a bath or shower
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens or symptoms persist more than 7 days
- symptoms clear up and occur again within a few days
- excessive skin irritation occurs
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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.
Indications & Usage
Directions
- open pouch and remove patch
- carefully peel off protective packing and apply sticky side to affected area
- adults and children 12 years of age and older:
- do not wear patch for more than 8 hours
- apply to affected area no more than 3 times daily
- children under 12 years of age: consult a doctor
Storage And Handling
Other information
- store at room temperature 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients
aloe vera, aluminum hydroxide, BHT, castor oil, concentrated glycerin, disodium edetate hydrate, dried aluminum hydroxide gel, gelatin, isopropyl myristate, kaolin, magnesium aluminosilicate, methyl paraben, peg monostearate, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric dioxide, tocopherol acetate
Dosage & Administration
DISTRIBUTED BY
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY
CHESAPEAKE, VA 23320
MADE IN KOREA
Package Label.Principal Display Panel
6159.1 (6159.1)
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