Icy Hot With Lidocaine No-mess Applicator

Icy Hot With Lidocaine No-mess Applicator
SPL v3
SPL
SPL Set ID b090cdce-d17b-b4ff-e053-2995a90aaa70
Route
TOPICAL
Published
Effective Date 2018-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g) Menthol (1 g)
Inactive Ingredients
Cetyl Alcohol Dimethicone Edetate Disodium Isopropyl Alcohol Phenoxyethanol Dihexadecyl Phosphate Ethylhexylglycerin Polysorbate 60 Stearyl Alcohol Ceteth-10 Phosphate Caprylyl Trisiloxane Aminomethylpropanol Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Cetostearyl Alcohol Aloe Vera Leaf Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-30

Description

ICY H OT   with L IDOCAINE NO MESS Drug Facts

Purpose

Lidocaine HCl 4%............................................................................................................................Topical anesthetic Menthol 1%.......................................................................................................................................Topical analgesic


Medication Information

Purpose

Lidocaine HCl 4%............................................................................................................................Topical anesthetic Menthol 1%.......................................................................................................................................Topical analgesic

Description

ICY H OT   with L IDOCAINE NO MESS Drug Facts

Use

temporarily relieves minor pain

Prin

Section 42229-5

ICY H OT   with L IDOCAINE NO MESS

Drug Facts

Purposes

Lidocaine HCl 4%............................................................................................................................Topical anesthetic

Menthol 1%.......................................................................................................................................Topical analgesic

Warnings

For external use only

Directions

adults and children over 12 years:

■ apply a thin layer to affected area not more than 3 to 4 times daily

■ massage into painful area until thoroughly absorbed into skin

IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

children 12 years or younger: ask a doctor

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

Active Ingredients

Lidocaine HCL

Menthol

Inactive Ingredients

2-amino-2methylpropanol, acrylates/C10-30 alkyl acrylate crosspolymer, aloe vera juice, caprylyl methicone, cetearyl alcohol, cetyl alcohol, ceteth-10 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, isopropyl alcohol, phenoxyethanol, polysorbate 60, purified water, stearyl alcohol

When Using This Product

 use only as directed. Read and follow all directions and warnings on this carton.

■ avoid contact with 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

■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use

■ 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

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.


Structured Label Content

Use

temporarily relieves minor pain

Prin (PRIN)

Section 42229-5 (42229-5)

ICY H OT   with L IDOCAINE NO MESS

Drug Facts

Purposes

Lidocaine HCl 4%............................................................................................................................Topical anesthetic

Menthol 1%.......................................................................................................................................Topical analgesic

Warnings

For external use only

Directions

adults and children over 12 years:

■ apply a thin layer to affected area not more than 3 to 4 times daily

■ massage into painful area until thoroughly absorbed into skin

IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

children 12 years or younger: ask a doctor

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

Active Ingredients (Active ingredients)

Lidocaine HCL

Menthol

Inactive Ingredients (Inactive ingredients)

2-amino-2methylpropanol, acrylates/C10-30 alkyl acrylate crosspolymer, aloe vera juice, caprylyl methicone, cetearyl alcohol, cetyl alcohol, ceteth-10 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, isopropyl alcohol, phenoxyethanol, polysorbate 60, purified water, stearyl alcohol

When Using This Product (When using this product)

 use only as directed. Read and follow all directions and warnings on this carton.

■ avoid contact with 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

■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use

■ 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

■ 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

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

ask a health professional before use.

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.


Advanced Ingredient Data


Raw Label Data

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