Healthwise Pain Relief Cream With 4% Lidocaine

Healthwise Pain Relief Cream With 4% Lidocaine
SPL v3
SPL
SPL Set ID ef176d33-10b9-ddb2-e053-2995a90a76e3
Route
TOPICAL
Published
Effective Date 2022-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Water Alcohol Isohexadecane Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Dimethicone Cyclomethicone 5 Dihexadecyl Phosphate Glyceryl Monostearate Aloe Vera Leaf Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Phenoxyethanol Ethylhexylglycerin Aminomethylpropanol Steareth-21 Edetate Disodium Carbomer Interpolymer Type A (allyl Sucrose Crosslinked)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-01

Description

HealthWise Pain Relief Cream with 4% Lidocaine, 1.75 oz Drug Facts

Purpose

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


Medication Information

Purpose

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

Description

HealthWise Pain Relief Cream with 4% Lidocaine, 1.75 oz Drug Facts

Use

temporarily relieves minor pain

Section 42229-5

HealthWise Pain Relief Cream with 4% Lidocaine, 1.75 oz

Drug Facts

Warnings

For external use only

Avoid contact with eyes

Directions

adults and children over 12 years:

■ apply a thin layer to the affected area every 6 to 8 hours, not to exceed 3 applications in a 24-hour period

■ 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 Ingredient

Lidocaine HCI 4%

Inactive Ingredients

alcohol, aloe vera leaf, aminomethylpropanol, carbomer interpolymer type a, cyclomethicone 5, dihexadecyl phosphate, dimethicone, dimethicone/vinyl dimethicone crosspolymer, edetate disodium, ethylhexylglycerin, glyceryl monostearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, phenoxyethanol, steareth-21, water

Principal Display Panel

When Using This Product

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

■ do not allow contact with the eyes

do not bandage or apply local heat (such as heating pads) to the area of use

Stop Use and Ask A Doctor If

condition worsens

■ symptoms persist for more than 7 days or clear up and occur again within a few days

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 (1-800-222-1222) right away.


Structured Label Content

Use

temporarily relieves minor pain

Section 42229-5 (42229-5)

HealthWise Pain Relief Cream with 4% Lidocaine, 1.75 oz

Drug Facts

Purpose

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

Warnings

For external use only

Avoid contact with eyes

Directions

adults and children over 12 years:

■ apply a thin layer to the affected area every 6 to 8 hours, not to exceed 3 applications in a 24-hour period

■ 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 Ingredient (Active ingredient)

Lidocaine HCI 4%

Inactive Ingredients (Inactive ingredients)

alcohol, aloe vera leaf, aminomethylpropanol, carbomer interpolymer type a, cyclomethicone 5, dihexadecyl phosphate, dimethicone, dimethicone/vinyl dimethicone crosspolymer, edetate disodium, ethylhexylglycerin, glyceryl monostearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, phenoxyethanol, steareth-21, water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (When using this product)

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

■ do not allow contact with the eyes

do not bandage or apply local heat (such as heating pads) to the area of use

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens

■ symptoms persist for more than 7 days or clear up and occur again within a few days

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 (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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