BIOFREEZE PROFESSIONAL COLORLESS ROLL-ON- menthol, unspecified form 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

INN (International Name):

MENTHOL, UNSPECIFIED FORM

Composition:

MENTHOL, UNSPECIFIED FORM 50 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain Relieving Gel 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 PROFESSIONAL COLORLESS ROLL-ON- MENTHOL, UNSPECIFIED
FORM GEL
RB HEALTH (US) 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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BIOFREEZE PROFESSIONAL COLORLESS ROLL-ON
_DRUG FACTS_
ACTIVE INGREDIENT
Menthol 5%
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 BREAST-FEEDING, 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, Boswellia Carterii Resin Extract, Calendula
Officinalis Extract, Camellia
Sinensis Leaf Extract, Carbomer, Glycerin, Ilex Paraguariensis Leaf
Extract, Isopropyl
Alcohol, Isopropyl Myristate, Melissa Officina