PAIN RELIEF- capsaicin, menthol patch

Pain Relief by

Drug Labeling and Warnings

Pain Relief by is a Otc medication manufactured, distributed, or labeled by Bdk Group, Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Capsaicin 0.25%
Menthol 1.25%

Purpose

Topical Analgesic

Uses

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

simple backache arthritis strains bruises sprains.

Warnings

For external use only.

When using this product

avoid contact with the eyes and other mucous membranes

do not apply to wounds or damaged skin

do not bandage tightly 

do not use at the same time as other topical analgesics

use only as directed

Stop use and ask a doctor if condition worsens  symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults over 18 years:

to use the patch, carefully remove the backing film and apply to the affected area not more than 3 to 4 times daily

each patch can be worn up to 12 hours

children under 18 years of age: consult a doctor

Other information

store in a cool, dry place

Inactive ingredients

bentonite, ethylhexylacrylate, cannabidiol 15 mg, methacrylic acid, sodium stearate

Questions or comments?

310.909.8407 l lamend.com

You may also report serious side effects to this phone number.

SPL UNCLASSIFIED SECTION

Stiff neck, backache, or joint pain cramping your style? This topical & transdermal patch temporarily alleviates mild to moderate discomfort in muscles and joints.

Distributed by La Mend

PO Box 946

Chattanooga, TN 37401

Made in the USA

Packaging

INGREDIENTS AND APPEARANCE

PAIN RELIEF 
capsaicin, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72587-112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.25 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	1.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BENTONITE (UNII: A3N5ZCN45C)
2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)
CANNABIDIOL (UNII: 19GBJ60SN5)
METHACRYLIC ACID (UNII: 1CS02G8656)
SODIUM STEARATE (UNII: QU7E2XA9TG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72587-112-23	1 in 1 POUCH	10/01/2018
1		0.0025 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	10/01/2018

Labeler - Bdk Group, Llc (036500371)