Icy Hot Cream

Icy Hot Cream
SPL v6
SPL
SPL Set ID 75b28b06-77ea-4fea-b516-2e8a0dac7037
Route
TOPICAL
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.4 g) Menthol (0.1 g)
Inactive Ingredients
Alcohol Aloe Vera Leaf Aminomethylpropanol C30-45 Alkyl Cetearyl Dimethicone Crosspolymer Caprylyl Methicone Cetostearyl Alcohol Ceteth-20 Phosphate Dicetyl Phosphate Dimethicone Edetate Disodium Ethylhexylglycerin Glyceryl Stearate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Isohexadecane Methylparaben Polysorbate 60 Steareth-21 Water Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s At 1.0%)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-03-01

Description

ICY H OT ®    with LIDOCAINE PAIN RELIEVING CREAM Drug Facts

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

ICY H OT ®    with LIDOCAINE PAIN RELIEVING CREAM Drug Facts

Use

for the temporary relief of pain

Section 42229-5

ICY H OT ®    with LIDOCAINE

PAIN RELIEVING CREAM

Drug Facts

Purposes

Topical anesthetic

Warnings

For external use only

Directions

■ adults and children 12 years of age and older:

      ■ apply a thin layer to affected area every 6 to 8 hours, not more than 3 to 4 times daily

      ■ massage until thoroughly absorbed into skin

      ■ wash hands thoroughly with soap and water after each use

■ children under 12 years of age: ask a doctor

Do Not Use

■ in large quantities

■ on wounds or on irritated or damaged skin

■ with a heating pad

Active Ingredients

Lidocaine HCl 4%

Inactive Ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat. (15%), 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, methylparaben, polysorbate 60, steareth-21, water

Keep Carton As It Contains Important Information

Close cap tightly between uses.

Principal Display Panel

ICY HOT

MAX

LIDOCAINE

PAIN RELIEF CREAM

Net Wt 2.7 OZ (76.5 g)

When Using This Product

use only as directed

■ do not bandage tightly

■ avoid contact with eyes and mucous membranes

■ do not expose the area to local heat or to direct sunlight

rare cases of serious burns have been reported with products of this type

■ 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 or symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days

■ redness is present or excessive skin irritation occurs

■ you experience severe burning pain, swelling, or blistering where the product was applied

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children and Pets.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use

for the temporary relief of pain

Section 42229-5 (42229-5)

ICY H OT ®    with LIDOCAINE

PAIN RELIEVING CREAM

Drug Facts

Purposes

Topical anesthetic

Warnings

For external use only

Directions

■ adults and children 12 years of age and older:

      ■ apply a thin layer to affected area every 6 to 8 hours, not more than 3 to 4 times daily

      ■ massage until thoroughly absorbed into skin

      ■ wash hands thoroughly with soap and water after each use

■ children under 12 years of age: ask a doctor

Do Not Use (Do not use)

■ in large quantities

■ on wounds or on irritated or damaged skin

■ with a heating pad

Active Ingredients

Lidocaine HCl 4%

Inactive Ingredients (Inactive ingredients)

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat. (15%), 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, methylparaben, polysorbate 60, steareth-21, water

Keep Carton As It Contains Important Information

Close cap tightly between uses.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ICY HOT

MAX

LIDOCAINE

PAIN RELIEF CREAM

Net Wt 2.7 OZ (76.5 g)

When Using This Product (When using this product)

use only as directed

■ do not bandage tightly

■ avoid contact with eyes and mucous membranes

■ do not expose the area to local heat or to direct sunlight

rare cases of serious burns have been reported with products of this type

■ 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 (Stop use and ask a doctor if)

condition worsens or symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days

■ redness is present or excessive skin irritation occurs

■ you experience severe burning pain, swelling, or blistering where the product was applied

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children and Pets. (Keep out of reach of children and pets.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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