SOOTHE- capsaicin, menthol patch

Soothe by

Drug Labeling and Warnings

Soothe by is a Otc medication manufactured, distributed, or labeled by La Mend, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Capsaicin 0.25%
Menthol 5%

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 use only as directed

Do not use more than one patch at a time

at the same time as other topical analgesics

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:

use one 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

reseal the envelope by squeezing seal together

Inactive ingredients

bentonite, ethylhexylacrylate, 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

Temporarily soothe your pain. A topical patch made to alleviate mild to moderate discomfort in muscles and joints.
Let’s get you moving again!

Distributed by La Mend

PO Box 946

Chattanooga, TN 37401

Made in the USA

Packaging

INGREDIENTS AND APPEARANCE

SOOTHE 
capsaicin, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72587-111
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	5 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72587-111-22	4 in 1 POUCH	10/01/2018
1		0.009 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)