Topcare Cold And Hot Pain Relieving
FDA Label NDC 76162-180

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 Topcare Cold And Hot Pain Relieving (NDC 76162-180). 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, discontinue use and consult a doctor if, otc - pregnancy or breast feeding, 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 ingredientsPurpose
Lidocaine HCl 4%Topical analgesic
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 carton
  • ◆rare cases of serious burns have been reported with products of this type
  • ◆do not bandage or apply local heat (such as heating pads) to the area of use with a medicated patch
  • ◆avoid contact with eyes and mucous membranes
  • ◆a transient burning sensation may occur upon application but generally disappears in several days

Discontinue Use And Consult 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

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 (1-800-222-1222) immediately.

Directions

Adults and children over 12 years:

  • ◆Apply to affected area not more than 3 to 4 times daily
  • ◆AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

    • children under 12 years or younger: ask a doctor

Other Information

store at room temperature

Inactive Ingredients

acrylates/C10-30 alkyl Acrylate crosspolymer, alcohol denat., aloe barbadensis leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, phenoxyethanol, polysorbate 60, steareth-21, water.

Questions Or Comments?

1-888-423-0139

Principal Display Panel - 77 G Bottle Carton

TopCare®
health

COMPARE TO ICY HOT® ACTIVE INGREDIENTS*

MAXIMUM STRENGTH LIDOCAINE

Cold & Hot
Pain Relieving
Lidocaine Cream

4% Lidocaine • 1% Menthol

LIDOCAINE 4% / TOPICAL ANALGESIC
MENTHOL 1% / TOPICAL ANALGESIC

  • Helps to Numb Away Pain
  • Non-Greasy
  • Maximum Strength External
    Analgesic with 4% Lidocaine

    • NET WT 2.7 OZ (77 g)

    Principal Display Panel (77 g Bottle Carton)

    Principal Display Panel (77 g Bottle Carton)

* Please review the disclaimer below.