Drug Facts

Active ingredients

Camphor 9.6%

Capsicum containing 0.05% Capsaicin

Menthol 7.8%

Purpose

External 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
do not apply to wounds or damaged skin
do not bandage tightly

Stop use and ask a doctor if

condition worsens
if 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.

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 from backing film and apply.
Remove from the skin after at most 8 hour's application
Apply to the affected area not more than 3 times daily.
Children under 12 years of age: Consult a doctor.

Inactive ingredients

Acrylic Acid, Aluminum Hydroxide, Carmellose Sodium 2-Ethylhexylacrylate, Glycerin, Methyl Acrylate, Polyacrylate, Polyacrylic Acid, Sodium Polyacrylate, Tartaric Acid, Water

Package Labeling:

Label

EXTERNAL ANALGESIC
camphor (synthetic), capsicum, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73567-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	96 mg in 1 mL
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSICUM	0.5 mg in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	78 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ACRYLIC ACID (UNII: J94PBK7X8S)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
GLYCERIN (UNII: PDC6A3C0OX)
METHYL ACRYLATE (UNII: WC487PR91H)
TARTARIC ACID (UNII: W4888I119H)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73567-001-00	1 in 1 POUCH	04/01/2020
1		8 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	04/01/2020

Labeler - Zhengzhou Daohe Medical Technology Co.,Ltd (406230407)

Name	Address	ID/FEI	Business Operations
Establishment
Zhengzhou Daohe Medical Technology Co.,Ltd		406230407	manufacture(73567-001)

EXTERNAL ANALGESIC PATCH