ASSURED PAIN RELIEF HOT PATCH- menthol, capsicum oleoresin patch

ASSURED PAIN RELIEF HOT PATCH by

Drug Labeling and Warnings

ASSURED PAIN RELIEF HOT PATCH by is a Otc medication manufactured, distributed, or labeled by GREENBRIER INTERNATIONAL, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                                         Purpose

Menthol 30mg...............................................................................Topical Analgesic

Capsicum Extract (capsaicin) 8.3mg...............................................Topical Analgesic

PURPOSE

Uses

Temporarily relieves minor pain associated with:

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

WARNINGS

Warnings

For external use only

PREGNANCY OR BREAST FEEDING

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

WHEN USING

When using this product

• use only as directed
• do not bandage tightly or use with a heating pad
• avoid contact with eyes and mucous membranes
• do not apply to wounds or damaged skin

STOP USE

Stop use and ask a doctor if

• condition worsens
• symptoms persist more than 7 days or clear up and occur again within a few days
• redness is present
• skin irritation develops
  

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.

INDICATIONS & USAGE

Directions

• Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
• Children under 12 years of age: do not use, consult a doctor
• For easy application: partially peel back protective film and apply exposed patch to site of pain
• Carefully remove remaining film while pressing patch to skin for secure adhesion
• Store unused patch in pouch.  Reseal pouch after opening
  

INACTIVE INGREDIENT

Inactive ingredients

aloe vera, aluminum hydroxide, disodium EDTA, gelatin, kaolin, methacrylic acid copolymer, methylparaben, polysorbate 80, sorbitan monostearate, sorbitol solution, tartaric acid, titanium dioxide, tocopheryl acetate (vitamin E), water

DOSAGE & ADMINISTRATION

Distributed by:

Greenbrier International, Inc.

500 Volvo Parkway

Chesapeake, VA 23320

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASSURED PAIN RELIEF HOT PATCH  
menthol, capsicum oleoresin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-1889
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	30 mg
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	8.3 mg

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GELATIN (UNII: 2G86QN327L)
KAOLIN (UNII: 24H4NWX5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SORBITOL (UNII: 506T60A25R)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-1889-2	1 in 1 BOX
1		2 in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/31/2013

Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)