FDA Label for Overnight Cold Therapy Pain Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL – 74 ML BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL – 89 ML TUBE LABEL
Overnight Cold Therapy Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Walgreen Co.. 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 Ingredient
Menthol 4%
Purpose
Topical Analgesic
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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 Extract, Arnica Montana Flower Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Camphor, Caprylic/Capric Triglyceride, Carbomer, Fragrance, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Ilex Paraguariensis Leaf Extract, Tocopheryl Acetate, Triethanolamine, Silicone Dioxide, Water
Principal Display Panel – 74 Ml Bottle Label
Walgreens
WALGREENS
PHARMACIST RECOMMENDED
Compare to the active ingredient
in Biofreeze®
Roll-On††
OVERNIGHT
Cold Therapy
Pain Relief
MENTHOL 4%/TOPICAL ANALGESIC
Roll On
No Mess
- For arthritis, back pain,
sore muscles & joints - Soothing menthol
- Paraben free
Lavender
scent
2.5 FL OZ (74 mL)
Principal Display Panel – 89 Ml Tube Label
Walgreens
WALGREENS
PHARMACIST RECOMMENDED
Compare to the active ingredient
in Biofreeze®
Overnight Gel††
OVERNIGHT
Cold
Therapy
Pain Relief
Gel
MENTHOL 4%/TOPICAL ANALGESIC
- For arthritis, back pain,
sore muscles & joints - Soothing menthol
- Paraben free
Lavender
scent
3 FL OZ (89 mL)
* Please review the disclaimer below.