EXTERNAL ANALGESIC (camphor- synthetic, capsicum, menthol patch

EXTERNAL ANALGESIC by

Drug Labeling and Warnings

EXTERNAL ANALGESIC by is a Otc medication manufactured, distributed, or labeled by Zhengzhou Daohe Medical Technology Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

EXTERNAL ANALGESIC 
camphor (synthetic), capsicum, menthol patch

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/01/2020

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

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