FDA Label for Pain Relief Extra Strength, Cooling
View Indications, Usage & Precautions
Pain Relief Extra Strength, Cooling Product Label
The following document was submitted to the FDA by the labeler of this product J.r. Watkins, 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.
Other
Drug Facts
Active Ingredient
Menthol 6%
Purpose
Topical Analgesic
Uses
For the temporary relief of 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 fire or flame and heated surfaces.
Do Not Use
- On open wounds, damaged or irritated skin
- With a heading pad or TENS device
- With any other creams, ointments, sprays, liniments, or other topical products containing menthol
When Using This Product
- Do not bandage tightly
- Use only as directed
- Avoid contact with eyes or mucous membranes
- Contents under pressure
- Do not puncture or incinerate
- Do not store at temperature above 120 deg. F
Stop Use And Ask A Doctor If
- Condition worsens
- you have sensitive skin
- Rash, itching, redness, or excessive irritation of skin develops
- Symptoms persist for more than 7 days
- Symptoms clear up and occur again within a few days
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding: 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 12 years of age and older:
- Apply to affected area not more 4 times a day
- Massage painful area until absorbed into skin
- Wash hands after each use with cold water
- Children under 12 years of age: consult a doctor.
Other Information
- Store away from children
- Store in dry, well-ventilated conditions at room temperature (59-77°F)
Inactive Ingredients
Aloe barbadensis leaf extract, Arnica montana flower extract, denatured alcohol, glycerin, Melaleuca alternafolia (tea tree) leaf oil, organic Ilex paraguariensis (yerba mate) leaf, tocopheryl acetate (vitamin E), water
Questions Or Comments?
J.R WATKINS, LLC
OAKLAND, CA 94612
1-888-384-1945
JRWATKINS.COM
Principal Display Panel - 118 Ml Bottle Label
EXTRA STRENGTH*
ESTD
1868
J.R.
WATKINS
REMEDIES FOR BODY™
COOLING
PAIN RELIEF SPRAY
WITH NATURAL MENTHOL,
ARNICA & VITAMIN E
FAST-ACTING MENTHOL
PAIN RELIEF FOR
BACKACHES, SORE MUSCLES,
& JOINT PAIN
4.0 fl oz (118 mL)
USED BY
ATHLETES
* Please review the disclaimer below.