BIOFREEZE MENTHOL- menthol, unspecified form patch

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:

Pain Relieving Patch 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- MENTHOL, UNSPECIFIED FORM PATCH
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
MENTHOL PATCHES
_DRUG FACTS_
ACTIVE INGREDIENT
Menthol 5%
PURPOSE
Pain Relieving Patch
USES
Temporarily relieves minor aches and pains of muscles and joints
associated with:
simple backache
arthritis
strains
bruises
sprains
WARNINGS
FOR EXTERNAL USE ONLY.
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
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 12 years of age and older: Clean and dry affected
area, pop apart
and partially peel back protective film and apply exposed patch to
site of pain.
Carefully remove remaining film while pressing the patch to skin and
leave in place for
up to 8 hours. Use on affected area not more than 3 to 4 times daily.
children under 12 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, Arnica Montana Flower Extract,
Boswellia Carterii Resin
Extract, Camellia Sinensis Leaf Extract, Cellulose Gum,
Dihydroxyaluminum
Aminoacetate, Ethylhexylglycerin, Glycerin, Iodopropynyl
Butylcarbamate, Kaolin, M