FDA Label for Biofreeze Roll-on
View Indications, Usage & Precautions
- DRUG FACTS
- ACTIVE INGREDIENTS
- PURPOSE
- USES:
- WARNINGS:
- FLAMMABLE:
- ASK A DOCTOR BEFORE USE IF YOU HAVE:
- WHEN USING THIS PRODUCT:
- STOP USE AND ASK A DOCTOR IF:
- IF PREGNANT OR BREAST-FEEDING:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS
- INACTIVE INGREDIENTS:
- OTHER INFORMATION:
- QUESTIONS OR COMMENTS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- PRODUCT LABEL
Biofreeze Roll-on Product Label
The following document was submitted to the FDA by the labeler of this product Rb Health (us) Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active Ingredients
Menthol USP 4%
Purpose
Cooling Pain Relief
Uses:
Temporary relief from minor aches and pains of sore muscles and joints associated with: - arthritis, - backache, - strains, - sprains
Warnings:
For external use only
Flammable:
Keep away from excessive heat or open flame
Ask A Doctor Before Use If You Have:
Sensitive skin
When Using This Product:
- Avoid contact with 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 skin irritation develops.
- Do not bandage
- Wash hands after use with cool water
- Do not use with heating pad or device.
Stop Use And Ask A Doctor If:
Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur
If Pregnant Or Breast-Feeding:
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.
Directions
Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary
Children under 2 years of age: Consult physician
Inactive Ingredients:
Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Arctium Lappa Root (Burdock) Extract, Boswellia Carteril Resin Extract, Calendula Officinallis Extract, Carbomer, Camellia Sinensis (Green Tea) Leaf Extract, Camphor USP, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Ispropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silicon Dioxide, Tocopheryl (Vitamin E) Acetate, Triethanolamine, Purified Water USP, Blue 1, Yellow 5
Other Information:
Store in a cool dry place with lid closed tightly
Questions Or Comments
1-800-246-3733
Package Label.Principal Display Panel
BIOFREEZE COLD THERAPY PAIN RELIEF ROLL-ON for arthritis, back pain, sore muscles and joints SOOTHING MENTHOL - VANISHING SCENT - PARABEN-FREE 3 fl oz / 89 mL SHAKE WELL BEFORE EACH USE Apply by rolling in only one direction. Do not use a circular motion. NO NSAIDS, IBUPROFEN, ASPIRIN OR SALICYLATE Manufactured in the U.S.A. No Animal Testing
Product Label
* Please review the disclaimer below.