Cool N Heat Lidocaine Dry
FDA Label NDC 36800-850

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Cool N Heat Lidocaine Dry (NDC 36800-850). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if, extremely flammable, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

Otc - Purpose

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)

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*

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Cool n' Heat
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LIDOCAINE 4% / TOPICAL ANESTHETIC
MENTHOL 1% / TOPICAL ANALGESIC

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CONTINUOUS SPRAY

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    Principal Display Panel (113 g Can Label)

    Principal Display Panel (113 g Can Label)

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