FDA Label for Cool N Heat Lidocaine Dry
View Indications, Usage & Precautions
Cool N Heat Lidocaine Dry Product Label
The following document was submitted to the FDA by the labeler of this product Topco Associates 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
DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007
Otc - Purpose
Active ingredients | Purposes |
---|---|
Lidocaine 4% | Topical anesthetic |
Menthol 1% | Topical analgesic |
Use
temporarily relieves minor pain
Warnings
For external use only
Do Not Use
- on large areas of the body or on cut, irritated or swollen skin
- on puncture wounds
- for more than one week without consulting a doctor
When Using This Product
- use only as directed. Read and follow all directions and warnings on this label
- do not allow contact with the eyes and mucous membranes
- rare cases of serious burns have been reported with products of this type
- do not apply to wounds or damaged, broken or irritated skin
- avoid spraying on face
- avoid inhalation of spray
- do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use
- do not use at the same time as other topical analgesics
- a transient burning sensation may occur upon application but generally disappears in several days
- avoid applying into skin folds
Stop Use And Ask A Doctor If
- condition worsens
- redness is present
- irritation develops
- symptoms persist for more than 7 days or clear up and occur again within a few days
- you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
Extremely Flammable
- do not use near heat or flame or while smoking
- avoid long term storage above 104°F (40°C)
- do not puncture or incinerate. Contents under pressure
- do not store at temperatures above 120°F (49°C)
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 over 12 years :
- spray affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
- product will dry quickly on its own, and does not need to be rubbed in
children 12 years or younger: ask a doctor
Inactive Ingredients
caprylic/capric triglyceride, isobutane, propylene glycol, SD alcohol 40B (30 %)
Questions Or Comments?
1-888-577-8033
Principal Display Panel - 113 G Can Label
NDC 36800-908-35
TopCare
health®
COMPARE TO ICY HOT® LIDOCAINE PLUS
MENTHOL DRY SPRAY ACTIVE INGREDIENTS*
MAXIMUM STRENGTH
Cool n' Heat
Dry Spray
Pain Relief
with Lidocaine + Menthol
LIDOCAINE 4% / TOPICAL ANESTHETIC
MENTHOL 1% / TOPICAL ANALGESIC
•OUR PHARMACISTS•
RECOMMEND
CONTINUOUS SPRAY
- Temporarily Numbs
Pain Away - Dries Instantly
- Non-Greasy
✓QUALITY
GUARANTEED
NET WT 4 OZ (113 g)
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