Soundybody Lidocaine Creme

Soundybody Lidocaine Creme
SPL v4
SPL
SPL Set ID 9ee572b6-4f0a-69d5-e053-2995a90aed51
Route
TOPICAL
Published
Effective Date 2020-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.4 g)
Inactive Ingredients
Carbomer Interpolymer Type A (55000 Cps) Aloe Vera Leaf Aminomethylpropanol Caprylyl Trisiloxane Cyclomethicone 5 Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Dihexadecyl Phosphate Dimethicone Edetate Disodium Ethylhexylglycerin Glyceryl Monostearate Isohexadecane Polysorbate 60 Alcohol Steareth-21 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-02-17

Description

SOUNDBODY LIDOCAINE PAIN RELIEVING CREAM Drug Facts

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

SOUNDBODY LIDOCAINE PAIN RELIEVING CREAM Drug Facts

Uses

Temporarily relieves minor pain

Section 42229-5

SOUNDBODY

LIDOCAINE

PAIN RELIEVING CREAM

Drug Facts

Purposes

Topical anesthetic

Warnings

For external use only

Directions

adults and children over 12 years:

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

  • AFTER APPLYING, WASH HANDS 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 4%

Inactive Ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, cetearyl alcohol(and)dicetyl phosphate(and)ceteth-10 phosphate, cyclopentasiloxane, dimethicone, dimethicone/vinyl dimethicone crosspolymer, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate / sodium acryloyldimethyl taurate copolymer, isohexadecane, phenoxyethanol, SD alcohol 40 (15%), steareth-21, water

Principal Display Panel

SOUNDBODY



Lidocaine



Plus Menthol



Pain Relieving Cream

When Using This Product
  • Use only as directed. Read and follow all directions and warnings on this label

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

  • do not bandage tightly or apply local heat (such as heating pads) to the area of use or 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
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 and Pets.

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


Structured Label Content

Uses

Temporarily relieves minor pain

Section 42229-5 (42229-5)

SOUNDBODY

LIDOCAINE

PAIN RELIEVING CREAM

Drug Facts

Purposes

Topical anesthetic

Warnings

For external use only

Directions

adults and children over 12 years:

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

  • AFTER APPLYING, WASH HANDS 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

Lidocaine HCl 4%

Inactive Ingredients (Inactive ingredients)

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, cetearyl alcohol(and)dicetyl phosphate(and)ceteth-10 phosphate, cyclopentasiloxane, dimethicone, dimethicone/vinyl dimethicone crosspolymer, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate / sodium acryloyldimethyl taurate copolymer, isohexadecane, phenoxyethanol, SD alcohol 40 (15%), steareth-21, water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

SOUNDBODY



Lidocaine



Plus Menthol



Pain Relieving Cream

When Using This Product (When using this product)
  • Use only as directed. Read and follow all directions and warnings on this label

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

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