BIOFREEZE- menthol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)

Available from:

RB Health (US) LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Temporarily relieves minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains

Authorization status:

OTC monograph not final

Summary of Product characteristics

BIOFREEZE- MENTHOL GEL
RB HEALTH (US) LLC
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BIOFREEZE
_DRUG FACTS_
_ACTIVE INGREDIENTS:_
Menthol USP 4%
_PURPOSE_
Pain Relieving Gel
_USES:_
Temporarily relieves minor aches and pains of muscles and joints
associated with: •
simple backache • arthritis • strains • bruises • sprains
_WARNINGS:_
FOR EXTERNAL USE ONLY
FLAMMABLE: KEEP AWAY FROM EXCESSIVE HEAT OR OPEN FLAME
WHEN USING THIS PRODUCT:
• Use only as directed • Avoid contact with the eyes or on mucous
membranes • Do not
apply to wounds or damaged skin • Do not apply to irritated skin or
if excessive irritation
develops • Do not bandage tightly or use with heating pad or device
STOP USE AND ASK A DOCTOR IF:
You experience pain, swelling or blistering of the skin; condition
worsens, or if
symptoms persist for more than 7 days, or clear up and occur again
within a few days;
arthritic pain persists for more than 10 days, or redness is present,
or in conditions
affecting children under 12 years of age
IF PREGNANT OR BREASTFEEDING:
Ask a health professional before use
KEEP OUT OF REACH OF CHILDREN:
If swallowed, get medical help or contact a Poison Control Center
right away
®
_DIRECTIONS:_
ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER:Rub a thin film over
affected area
not more than 3 to 4 times daily
CHILDREN UNDER 2 YEARS OF AGE:Consult a physician
wash hands after use with cool water
OTHER INFORMATION
- store at 20-25°C (68-77°F) - store in a cool dry place away from
direct sunlight
_INACTIVE INGREDIENTS:_
Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock) Extract,
Arnica Montana
Flower Extract, Blue 1, Boswellia Carterii Resin Extract, Calendula
Officinalis Extract,
Camellia Sinensis Leaf Extract, Camphor, Carbomer, Glycerin, Ilex
Paraguariensis Leaf
Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis
(Lemon Balm) Leaf
Extract, Silica, Tocopheryl Acetate, Triethanolamine, Water, Yellow 5
_QUESTIONS OR COMMENTS:_ 1-800-246-3733
Dist. by: RB Health (US)
Parsippany, NJ 07054-0224
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