FDA Label for Biofreeze
View Indications, Usage & Precautions
- 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:
- OTHER INFORMATION:
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS
- REPRESENTATIVE LABELING
Biofreeze 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.
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 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 irritated 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 recur
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
Other Information:
Store in a cool dry place with lid closed tightly
Inactive Ingredients
Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Arctium Lappa Root (Burdock) Extract, Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Carbomer, Camellia Sinensis Leaf Extract , Camphor USP, Glycerin, Ilex Paraguariensis Leaf Extract (Green Tea), Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silicon Dioxide, Tocopheryl (Vitamine E) Acetate, Triethanolamine, Purified Water USP, Blue 1, Yellow 5
Questions Or Comments
1-800-246-3733
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