GERIGENTLE FROSTYHEAT PAIN RELIEF PATCH BACK- menthol patch

GeriGentle FrostyHeat Pain Relief Patch Back by

Drug Labeling and Warnings

GeriGentle FrostyHeat Pain Relief Patch Back by is a Otc medication manufactured, distributed, or labeled by Geri-Gentle Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Menthol 5%

Purpose

Topical anesthetic

Use

• Temporarily relieves minor aches and pains of muscles and joints due to
• arthritis
• simple backache
• strains
• sprains
• bruises.

Warnings:

For external use only

Do not use

• on wounds or damaged skin
• with heating pad
• if you are allergic to any ingredient of this product.

When using this product

• use only as directed
• avoid contact with eyes and mucous membranes or rashes

Stop use and ask a doctor if

• conditions worsen
• excessive redness or irritation is present
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days.

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children and pets.

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.

Children under 12 years of age: consult a physician.

• clean and dry affected area
• remove film from patch and apply to skin
• apply 1 patch at a time to affected area, not more than 3 to 4 times daily.
• wear each patch up to 8 hours maximum.

Other information:

• Avoid storing product in direct sunlight
• Protect product from excessive moisture

Inactive ingredients:

Glycerin, Sodium polyacrylate, Dihydroxyaluminum Aminoacetate, Methylparaben, Propylparaben, Titanium Dioxide, Kaolin, Polysorbate 80, Propylene Glycol, Tartaric Acid, PVP, Polyacrylic Acid, Water, Petrolatum, CMC, Mineral Oil.

Package Labeling:

INGREDIENTS AND APPEARANCE

GERIGENTLE FROSTYHEAT PAIN RELIEF PATCH BACK 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69771-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
KAOLIN (UNII: 24H4NWX5CO)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TARTARIC ACID (UNII: W4888I119H)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69771-012-05	5 in 1 POUCH	07/16/2022
1		0.0308 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/16/2022

Labeler - Geri-Gentle Corporation (080367686)