Biofreeze MENTHOL RB HEALTH (US) LLC FDA Approved Uses: Temporary relief from minor aches and pains of sore muscles and joints associated with: • arthritis • backache • strains • sprains

BIOFREEZE

Generic: MENTHOL
Mfr: RB HEALTH (US) LLC FDA OTC
FunFoxMeds box
Substance Menthol Unspecified Form
Route
TOPICAL
Applications
M017
Product NDC
59316-0869-00 59316-0869-10
Package NDC
59316-869-10

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredients: Menthol USP 10% Purpose Cooling Pain Relief
Inactive Ingredients
Inactive Ingredients: Caprylic/Capric Triglyceride Caprylyl Glycol Alcohol Dimethicone Gluconolactone Glycerin Glyceryl Stearate Hydroxyacetophenone Ilex Paraguariensis Leaf Extract Iodopropynyl Butylcarbamate Phenoxyethanol Polysorbate 60 Sodium Benzoate Sodium Hydroxide Sodium Stearoyl Lactylate Tocopheryl Acetate Vitis Vinifera (Grape) Seed Oil Water Calcium Gluconate Cetostearyl Alcohol Edetate Sodium Isopropyl Alcohol PEG-4 Laurate
Strengths
10 %
Treats Conditions
Uses Temporary Relief From Minor Aches And Pains Of Sore Muscles And Joints Associated With Arthritis Backache Strains Sprains

Identifiers & Packaging

Container Type UNKNOWN
NDC 59316-0869-00
All Product Codes
59316-0869-00 59316-0869-10
UNII
L7T10EIP3A
SPL Set IDs
a227213b-e89f-7144-e053-2a95a90a7e74
Packaging

Package Labeling: Label

Package Descriptions
  • Package Labeling: Label
Overview

Uses: Temporary relief from minor aches and pains of sore muscles and joints associated with: • arthritis • backache • strains • sprains

Indications & Usage

Uses: Temporary relief from minor aches and pains of sore muscles and joints associated with: • arthritis • backache • strains • sprains

Dosage & Administration

Directions: • Adults and Children 12 years of age and older: Rub a thin film over affected areas not more four times daily; massage not necessary • Children under 12 years of age: Consult physician

Warnings & Precautions
Warnings: For external use only Ask a doctor before use if you have: Sensitive skin When using this product: • Avoid contact with the eyes or mucous membranes • Do not apply to wounds or damaged skin • Do not use with other ointments, creams, sprays or liniments • Do not apply to irritated skin or if excessive irritation develops • Do not bandage • Wash hands after use with cool water • Do not use with heating pad or device • Store in a cool dry place Stop use and ask a doctor if: Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur If pregnant or breastfeeding: Ask a health professional before use Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately
Purpose

Purpose Cooling Pain Relief

When Using

When using this product: • Avoid contact with the eyes or mucous membranes • Do not apply to wounds or damaged skin • Do not use with other ointments, creams, sprays or liniments • Do not apply to irritated skin or if excessive irritation develops • Do not bandage • Wash hands after use with cool water • Do not use with heating pad or device • Store in a cool dry place

Stop Use & Ask a Doctor

Stop use and ask a doctor if: Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur

Keep Out of Reach of Children

Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately

Questions

Questions or Comments: 1-800-246-3733

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Additional Information

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