SIGNATURE CARE MEDICATED COLD AND HOT PATCH- menthol patch

Signature Care Medicated Cold and Hot Patch by

Drug Labeling and Warnings

Signature Care Medicated Cold and Hot Patch by is a Otc medication manufactured, distributed, or labeled by Safeway, Foshan Aqua Gel Biotech Co., Ltd.,. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol 5%

Purpose

Topical analgesic

Use

For temporary relief of minor muscle and joint pain

Warning

For external use only

When using this product

■Use only as directed

■Rare cases of serious burns have been reported with products of this type

■Don't bandage tightly or use with heating pad

■ Avoid contact with eyes and mucous membranes

■Don't apply to wounds or damaged skin

■Do not use at the same time as other topical analgesics.

When using this product

Stop use and consult a doctor if

■ Condition worsens

■Redness is present

■Irritation develops
■Symptoms persist
for more than 7 days or clear up and occur again within a few days

■ You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

If pregnant or breastfeeding

ask a health professional before use

Keep out of reach of children

Keep out of reach of children. Do not use on infants. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Keep out of reach of children

Keep out of reach of children. Do not use on infants. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Adults and children 12 years of age and over: Carefully remove backing from patch. Apply sticky side of patch to affected area. Use one patch at a time. Repeat as necessary, but no more than 3 times daily. Discard patch after single use.
Reseal pouch after opening. Children under 12 years of age: consult a physician.

Other information

Store at room temperature, no to exceed 86F (30C)

Inactive Ingredients

Inactive ingredients
Carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, glycerin, iodopropynyl butylcarbamate, kaolin, mineral oil, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water, 3-(2-ethylhexyloxy)propane-1,2-diol

Questions

Toll Free 1-866-723-3929

Signature Care Medicated Cold & Hot Patch

INGREDIENTS AND APPEARANCE

SIGNATURE CARE MEDICATED COLD AND HOT PATCH 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-987
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
KAOLIN (UNII: 24H4NWX5CO)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE (UNII: FZ989GH94E)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

Product Characteristics
Color		Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-987-05	5 in 1 CARTON	11/01/2023
1		9 g in 1 PATCH; 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	11/01/2023

Labeler - Safeway (009137209)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co., Ltd.,		529128763	manufacture(21130-987)