MEDICATED PAIN RELIEF HOT- menthol, capsicum extract patch

Medicated Pain Relief Hot by

Drug Labeling and Warnings

Medicated Pain Relief Hot by is a Otc medication manufactured, distributed, or labeled by Kareway Product, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

L-Menthol 0.4%

Capsicum Extract (0.002% of Capsaicin)

Purposes

Topical analgesic

Topical analgesic

Uses

Temporarily relieves minor pain associated with:

• arthritis
• muscle strains
• simple backache
• bursitis
• cramps
• tendonitis
• muscle sprains
• bruises
  

Warnings

For external use only

When using this product

• use only as directed
• do not bandage tightly
• do not use a heating pad
• avoid contact with eyes and mucous membrane
• do not apply to wounds or damaged skin
• do not use if you are allergic to any ingredients of this product
  

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
• redness is present
• irritation develops

If pregnant or breast-feeding,

ask a health professional before use

Keep out of reach of children.

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

Directions

Adults and children 12 years of age and older: Clean and dry affected area. Remove backing film and apply not more than 3 to 4 times daily.

Children under 12 years of age: Consult a physician.

Other information

store at 20° to 25°C (68° to 77°F)

Inactive ingredients

aloe vera, disodium adetate, gelatine, glycerin, polyvinyl alcohol, purified water, sodium polyacrylate, tartaric acid, vitamin E acetate

Package label

Pain Relief Hot Patch

INGREDIENTS AND APPEARANCE

MEDICATED PAIN RELIEF HOT 
menthol, capsicum extract patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67510-0028
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	27.6 mg
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.25 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TARTARIC ACID (UNII: W4888I119H)
GELATIN (UNII: 2G86QN327L)
POLYVINYL ALCOHOL (UNII: 532B59J990)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67510-0028-2	1 in 1 CARTON	08/05/2019
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 67510-0028-4	1 in 1 CARTON	08/05/2019
2		4 in 1 POUCH; 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	09/16/2011

Labeler - Kareway Product, Inc. (121840057)