Drug Facts - Mentholatum Lidocaine Heat

Drug Facts - Mentholatum Lidocaine Heat
SPL v5
SPL
SPL Set ID cc2ef25a-b569-4d48-a666-899f710b4b34
Route
TOPICAL
Published
Effective Date 2018-10-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Alcohol Aloe Vera Leaf Aminomethylpropanol Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Caprylyl Trisiloxane Cetostearyl Alcohol Ceteth-20 Phosphate Chlorphenesin Dihexadecyl Phosphate Dimethicone Edetate Disodium Glycerin Glyceryl Monostearate Phenoxyethanol Polysorbate 20 Water Steareth-21 Vanillyl Butyl Ether

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-08-01

Description

Lidocaine HCl 4%

Purpose

Lidocaine HCl - Topical anesthetic


Medication Information

Purpose

Lidocaine HCl - Topical anesthetic

Description

Lidocaine HCl 4%

Uses

temporarily relieves pain

Warnings

For external use only

Directions
  • adults and children 12 years and over: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
  • children under 12 years: ask a doctor
Do Not Use
  • on large areas of the body or on cut, irritated or blistered 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, alcohol, aloe barbadensis leaf juice, aminomethyl propanol, bis-vinyl dimethicone/dimethicone copolymer, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, chlorphenesin, dicetyl phosphate, dimethicone, edetate disodium, glycerin, glyceryl monostearate, phenoxyethanol, polysorbate 20, purified water, steareth-21, vanillyl butyl ether

When Using This Product
  • use only as directed
  • do not get into eyes
  • do not bandage tightly or apply external heat 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
  • redness, rash, or irritation occurs
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.

Package/label Principal Display Panel

Structured Label Content

Uses

temporarily relieves pain

Purpose

Lidocaine HCl - Topical anesthetic

Warnings

For external use only

Directions
  • adults and children 12 years and over: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
  • children under 12 years: ask a doctor
Do Not Use (Do not use)
  • on large areas of the body or on cut, irritated or blistered skin
  • on puncture wounds
  • for more than one week without consulting a doctor
Active Ingredients (Active ingredients)

Lidocaine HCl 4%

Inactive Ingredients (Inactive ingredients)

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol, aloe barbadensis leaf juice, aminomethyl propanol, bis-vinyl dimethicone/dimethicone copolymer, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, chlorphenesin, dicetyl phosphate, dimethicone, edetate disodium, glycerin, glyceryl monostearate, phenoxyethanol, polysorbate 20, purified water, steareth-21, vanillyl butyl ether

When Using This Product (When using this product)
  • use only as directed
  • do not get into eyes
  • do not bandage tightly or apply external heat 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
  • redness, rash, or irritation occurs
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.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data


Raw Label Data

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