topcare®

topcare®
SPL v5
SPL
SPL Set ID e5ed6c88-5b78-449a-adb6-861d6f1d1f4a
Route
topical
Published
Effective Date 2022-08-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol, unspecified form (40 mg)
Inactive Ingredients
carbomer interpolymer type a (allyl sucrose crosslinked) alcohol aloe vera leaf aminomethylpropanol c30-45 alkyl cetearyl dimethicone crosspolymer caprylyl trisiloxane cetostearyl alcohol ceteth-20 phosphate dihexadecyl phosphate dimethicone edetate disodium ethylhexylglycerin glyceryl monostearate hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 mpa.s at 1.5%) isohexadecane phenoxyethanol polysorbate 60 steareth-21 water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph not final active Since 2022-05-24
Description

Drug Facts

Medication Information

Warnings

For external use only

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.

Description

Drug Facts

Use

temporarily relieves minor pain

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Section 53414-9

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

Section 55105-1
Active ingredients Purpose
Lidocaine HCl 4% Topical analgesic
Menthol 1% Topical analgesic
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
Questions Or Comments?

1-888-423-0139

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
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)

Structured Label Content

Warnings

For external use only

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 (Other information)

store at room temperature

Inactive Ingredients (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.

Use

temporarily relieves minor pain

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients Purpose
Lidocaine HCl 4% Topical analgesic
Menthol 1% Topical analgesic
Do Not Use (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
Questions Or Comments? (Questions or comments?)

1-888-423-0139

When Using This Product (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 (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
Principal Display Panel 77 G Bottle Carton (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)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:16.892526 · Updated: 2026-03-14T23:00:39.941399