Amazon Basics Cold & Hot Medicated Patch

Amazon Basics Cold and Hot Medicated Patch by

Drug Labeling and Warnings

Amazon Basics Cold and Hot Medicated Patch by is a Otc medication manufactured, distributed, or labeled by Amazon.com Services LLC, Foshan Aqua Gel Biotech Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

AMAZON BASICS COLD AND HOT MEDICATED PATCH- menthol patch 
Amazon.com Services LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Amazon Basics Cold & Hot Medicated Patch

Active Ingredient

Menthol 5%

Purpose

Topical analgesic

Use

For temporary relief of minor aches and pains of muscles and joints: arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps.

Warnings

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.

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

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. Wear one patch up to 8 hours. 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, not to exceed 86'F (30'C).

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

Amazon Basics Cold & Hot Medicated Patch

AMAZON BASICS COLD AND HOT MEDICATED PATCH 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72288-966
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)
WATER (UNII: 059QF0KO0R)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
PETROLATUM (UNII: 4T6H12BN9U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
POVIDONE (UNII: FZ989GH94E)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
KAOLIN (UNII: 24H4NWX5CO)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TARTARIC ACID (UNII: W4888I119H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72288-966-15	15 in 1 CARTON	01/01/2023
1		1 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 not final	part348	01/01/2023

Labeler - Amazon.com Services LLC (128990418)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co., Ltd.		529128763	manufacture(72288-966)

Revised: 1/2023

Document Id: f173605d-f5f2-7a98-e053-2a95a90aaa7d

34390-5

Set id: e3b4db12-c846-b984-e053-2a95a90a8e9a

Version: 2

Effective Time: 20230104