MMA ELITE PAIN RELIEF- menthol, camphor gel

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients      Purpose

Camphor (5%)          External Analgesic        
Menthol (5%)          External Analgesic

PURPOSE

Uses:

temporary relief of minor aches and pains of muscles
and joints due to:

    * simple backache
    * arthritis
    * sprains
    * strains
    * bruises

KEEP OUT OF REACH OF CHILDREN

Warnings:

    * for external use only
    * do not apply to open wounds or damaged skin
    * do not bandage tightly
    * avoid contact with eyes
    * Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center immediately
    * if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician
    * Pregnancy-breast feeding warning: if pregnant or breast feeding, ask a health professional before use
   

INACTIVE INGREDIENT

Inactive Ingredients:

distilled water, hamamelis virginiana (witch hazel extract),
isopropyl alcohol, arnica Montana, oleyl alcohol and
zanthoxylum alatum (scezhuan pepper), Bio-saccharide
Gum -1, glycerin, ammonium acryloyldimethyltaurate/VP
copolymer, beta cyclodextrin, menthol, potassium hydroxide,
mannitol, cellulose chromium, hydroxide green, tocopheryl
acetate (vitamin E), hydroxypropyl methycellulose

DOSAGE & ADMINISTRATION

Directions:

For best results, apply generously to affected and surrounding areas. Use 1 layer for minor pain, 2 for medium and 3 layers for severs symptoms.  Rub in well.  Allow to dry between layers (usually just 2-3 minutes).  Repeat process up to 4 times daily.  For adults and children 2 years and older.  For children under 2 years of age, consult a doctor. 

INDICATIONS & USAGE

Directions:

For best results, apply generously to affected and surrounding areas. Use 1 layer for minor pain, 2 for medium and 3 layers for severs symptoms.  Rub in well.  Allow to dry between layers (usually just 2-3 minutes).  Repeat process up to 4 times daily.  For adults and children 2 years and older.  For children under 2 years of age, consult a doctor.

Uses:

temporary relief of minor aches and pains of muscles
and joints due to:

    * simple backache
    * arthritis
    * sprains
    * strains
    * bruises

WARNINGS

Warnings:

    * for external use only
    * do not apply to open wounds or damaged skin
    * do not bandage tightly
    * avoid contact with eyes
    * Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center immediately
    * if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician
    * Pregnancy-breast feeding warning: if pregnant or breast feeding, ask a health professional before use

PRINCIPAL DISPLAY PANEL

An image/jpeg of the container label is included in this section.

 ID: MM1

INGREDIENTS AND APPEARANCE

MMA ELITE PAIN RELIEF 
menthol, camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24462-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A)	menthol	5 g  in 100 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
arnica montana (UNII: O80TY208ZW)
water (UNII: 059QF0KO0R)
Witch hazel (UNII: 101I4J0U34)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24462-200-04	1814 g in 1 JUG
2	NDC: 24462-200-03	177 g in 1 TUBE
3	NDC: 24462-200-01	2 g in 1 PACKET
4	NDC: 24462-200-02	88 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/10/2011

Labeler - MMA Pain Relief Gel, LLC (009985562)

Registrant - MMA Pain Relief Gel, LLC (009985562)

Establishment
Name	Address	ID/FEI	Business Operations
Northwest Cosmetic Labs		929572014	manufacture