Otc - Active Ingredient
Active Ingredients Purpose
Camphor (5%) External Analgesic
Menthol (5%) External Analgesic
Mma Elite Pain Relief
FDA Label NDC 24462-200
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mma Pain Relief Gel, Llc for the product Mma Elite Pain Relief (NDC 24462-200). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, inactive ingredient, dosage & administration, indications & usage, warnings, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses:temporary relief of minor aches and pains of musclesand joints due to: * simple backache * arthritis * sprains * strains * bruises
Otc - 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
Package Label.Principal Display Panel
An image/jpeg of the container label is included in this section.
ID: MM1
Bottle Label (Label)
* Please review the disclaimer below.
