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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Cool N' Heat Lidocaine Dry Spray

Drug Facts

Active ingredientsPurposes
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 :

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

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

✓QUALITY
GUARANTEED

NET WT 4 OZ (113 g)

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

PRINCIPAL DISPLAY PANEL - 113 g Can Label
COOL N HEAT LIDOCAINE DRY 
lidocaine and menthol, unspecified form spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-850
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ISOBUTANE (UNII: BXR49TP611)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-850-04113 g in 1 CAN; Type 0: Not a Combination Product05/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34805/01/2021
Labeler - TOPCO ASSOCIATES LLC (006935977)

Revised: 3/2021
Document Id: e78e00d4-40d8-4ca6-9e06-0b8ee220c20d
Set id: a0df12b6-d721-48fc-9eca-49f5431df04e
Version: 2
Effective Time: 20210308
 
TOPCO ASSOCIATES LLC