Label: MMA ELITE PAIN RELIEF- menthol, camphor gel
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Contains inactivated NDC Code(s)
NDC Code(s): 24462-200-01, 24462-200-02, 24462-200-03, 24462-200-04 - Packager: MMA Pain Relief Gel, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated November 18, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
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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
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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.
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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
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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
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INGREDIENTS AND APPEARANCE
MMA ELITE PAIN RELIEF
menthol, camphor gelProduct 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
