FDA Label for Biofreeze
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- FLAMMABLE
- ASK A DOCTOR BEFORE USE IF YOU HAVE:
- OTC - WHEN USING
- STOP USE AND ASK A DOCTOR IF:
- IF PREGNANT OR BREASTFEEDING:
- KEEP OUT OF THE REACH OF CHILDREN:
- DIRECTIONS
- OTHER INFORMATION:
- INACTIVE INGREDIENT
- QUESTIONS OR COMMENTS?
- BIOFREEZE - MENTHOL GEL (59316-101-10)
- BIOFREEZE - MENTHOL GEL (59316-101-11)
- BIOFREEZE - MENTHOL GEL (59316-101-13)
- BIOFREEZE - MENTHOL GEL (59316-101-12)
- BIOFREEZE - MENTHOL GEL (59316-101-15)
- BIOFREEZE - MENTHOL GEL (59316-101-20)
- BIOFREEZE - MENTHOL GEL (59316-101-30)
- BIOFREEZE - MENTHOL GEL (59316-101-50)
- BIOFREEZE - MENTHOL GEL (59316-101-40)
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 3.5%
Purpose
Cooling Pain Reliever
Uses
Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis - backache - strains - sprain
Warnings
For external use only.
Flammable
Keep away from excessive heat or open flame
Ask A Doctor Before Use If You Have:
sensitive skin
Otc - When Using
- 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 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 of symptoms persist for more than 7 days, or clear up and reoccur.
If Pregnant Or Breastfeeding:
Ask a health professional before use.
Keep Out Of The 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 Ingredient
- carbomer, FD and C blue # 1, FD and C yellow # 5, glycerine, herbal extract (llex paraguariensis), isopropyl alcohol USP, methylparaben, natural camphor USP (for scent), propylene glycol, silicon dioxide, triethanolamine, purified water U
Questions Or Comments?
1-330-633-8460
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