PAIN-RELIEVING ABDOMINAL BINDER cloth

Pain-Relieving Abdominal Binder by

Drug Labeling and Warnings

Pain-Relieving Abdominal Binder by is a Otc medication manufactured, distributed, or labeled by The Marena Group LLC, Textile-Based Delivery Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Capsaicin (synthetic) 0.16%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles associated with: bruises.

Warnings

For external use only.

Do not use

• If you are allergic to any ingredients in this product or to chili peppers, contact a doctor before use (allergy alert)
• On wounds or damaged skin
• With, or at the same time as, other external analgesic products
• With a heating pad

When using this product

• You may experience a burning sensation which is normal and related to the way the product works (with regular use, this sensation generally diminishes)
• Do not use immediately before or after activities such as swimming, showering, sunbathing or intense exercise
• Use only as directed
• Avoid contact with eyes and mucous membranes or rashes

Stop use and ask doctor if

• Condition worsens or persists for more than 7 days, or if symptoms clear up and occur again within a few days
• Rash, itching or excessive skin irritation develops

If pregnant or breastfeeding

Consult a healthcare professional before use.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Clean and dry affected area before use
• Remove product from packaging, open binder and place on abdomen making sure active ingredient is on the affected area (active ingredient is indicated by the lighter colored yarn on the inside of binder)
• Close binder by gently yet firmly pressing the closures together
• Wash hands after handling binder
• Maximum use of 10 hours per day
• Do not wear more than 6 days straight without doctor consent
• Hand wash separately from other clothes, with closure engaged

Other information

• Avoid storing product in direct sunlight
• Protect product from excessive moisture
• Active ingredient remains in effect for up to 15 washes

Inactive ingredient

acrylate copolymer

Principal Label

INGREDIENTS AND APPEARANCE

PAIN-RELIEVING ABDOMINAL BINDER 
pain-relieving abdominal binder cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84721-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.16 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)

Product Characteristics
Color		Score
Shape		Size	305mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84721-002-01	1 g in 1 POUCH; Type 0: Not a Combination Product	09/13/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	09/13/2024

Labeler - The Marena Group LLC (929793305)

Registrant - The Marena Group LLC (929793305)

Establishment
Name	Address	ID/FEI	Business Operations
Textile-Based Delivery Inc		079309716	api manufacture(84721-002)

Establishment
Name	Address	ID/FEI	Business Operations
The Marena Group LLC		929793305	label(84721-002) , pack(84721-002)