MMA ELITE PAIN RELIEF - menthol, camphor gel 
MMA Pain Relief Gel, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

Active Ingredients      Purpose

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








Uses:

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

    * simple backache
    * arthritis
    * sprains
    * strains
    * bruises


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 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

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. 

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:

    * 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

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

 ID: MM1bottle label

MMA ELITE PAIN RELIEF 
menthol, camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24462-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A) menthol5 g  in 100 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
arnica montana (UNII: O80TY208ZW)  
water (UNII: 059QF0KO0R)  
Witch hazel (UNII: 101I4J0U34)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24462-200-041814 g in 1 JUG
2NDC:24462-200-03177 g in 1 TUBE
3NDC:24462-200-012 g in 1 PACKET
4NDC:24462-200-0288 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/10/2011
Labeler - MMA Pain Relief Gel, LLC (009985562)
Registrant - MMA Pain Relief Gel, LLC (009985562)
Establishment
NameAddressID/FEIBusiness Operations
Northwest Cosmetic Labs929572014manufacture

Revised: 11/2011
Document Id: cc11fdde-5e58-488f-b736-176988e1f745
Set id: 259a912f-dcc2-4100-8062-51f5d5d71ea6
Version: 1
Effective Time: 20111118
 
MMA Pain Relief Gel, LLC