EXTERNAL ANALGESIC- camphor, capsicum, menthol patch

EXTERNAL ANALGESIC by

Drug Labeling and Warnings

EXTERNAL ANALGESIC by is a Otc medication manufactured, distributed, or labeled by Hmong 21. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Camphor 9.6%

Capsaicin 0.05%

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

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 synthoms oersust 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 hours' 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 polyacrylatem, Tartaric Acid, Water.

Label

INGREDIENTS AND APPEARANCE

EXTERNAL ANALGESIC 
camphor, capsicum, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70927-001
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 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.5 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	78 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
GLYCERIN (UNII: PDC6A3C0OX)
METHYL ACRYLATE (UNII: WC487PR91H)
TARTARIC ACID (UNII: W4888I119H)
WATER (UNII: 059QF0KO0R)
CAPSICUM (UNII: 00UK7646FG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70927-001-00	4 g in 1 PATCH; Type 0: Not a Combination Product	08/25/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/25/2016

Labeler - Hmong 21 (080352437)