COOL N HEAT LIDOCAINE DRY- lidocaine and menthol, unspecified form spray

Cool N Heat Lidocaine Dry by

Drug Labeling and Warnings

Cool N Heat Lidocaine Dry by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

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)

If pregnant or breast-feeding, ask a health professional before use.

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

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DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007

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)

Scan here for more
information or
call 1-888-423-0139

INGREDIENTS AND APPEARANCE

COOL N HEAT LIDOCAINE DRY 
lidocaine and menthol, unspecified form spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-850
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISOBUTANE (UNII: BXR49TP611)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-850-04	113 g in 1 CAN; Type 0: Not a Combination Product	05/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	05/01/2021

Labeler - TOPCO ASSOCIATES LLC (006935977)