Lidoguard Tm

Lidoguard Tm
SPL v1
SPL
SPL Set ID 531383aa-4f0f-4fe0-91f4-d809b39f160f
Route
TOPICAL
Published
Effective Date 2025-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Aloe Vera Leaf Juice Aminomethylpropanol Butylene Glycol Cetostearyl Alcohol Ceteth-10 Phosphate Dihexadecyl Phosphate Dimethicone, Unspecified Edetate Disodium Ethylhexylglycerin Glyceryl Monostearate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Phenoxyethanol Steareth-21 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-02
Description

Lidocaine HCl 4%.............................................Topical Analgesic

Medication Information

Description

Lidocaine HCl 4%.............................................Topical Analgesic

Uses

Temporarily relieves pain and itching due to:

  • minor cuts
  • sunburn
  • minor scrapes
  • minor burns
  • insect bites
  • minor skin irritations
Section 50570-1

Do not apply over large areas of the body

Section 55105-1

Warnings

For external use only.

Directions
  • Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily.
  • Children under 2 years: Consult a doctor.
Drug Facts

Questions?

Call 877-227-3137

Other Information
  • Store at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F)
Lnactive Lngredients

acrylates/c10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, butylene glycol, cetearyl alcohol, ceteth-10 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, phenoxyethanol, steareth-21, water

Principal Display Panel

LidoGuard TM Cream - NDC - 85231-200-30 - Pain Relieving Cream - Topical Analgesic - 1.05 oz (30 g)

Carton Label

Manufactured For:

ViolaCare, Inc.

Parsippany, New Jersey, 07054

When Using This Product
  • do not use in or near the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas
Stop Use and Ask A Doctor If
  • Allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredient                                           

Lidocaine HCl 4%.............................................Topical Analgesic

Structured Label Content

Uses

Temporarily relieves pain and itching due to:

  • minor cuts
  • sunburn
  • minor scrapes
  • minor burns
  • insect bites
  • minor skin irritations
Section 50570-1 (50570-1)

Do not apply over large areas of the body

Section 55105-1 (55105-1)

Warnings

For external use only.

Directions
  • Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily.
  • Children under 2 years: Consult a doctor.
Drug Facts

Questions?

Call 877-227-3137

Other Information (Other information)
  • Store at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F)
Lnactive Lngredients (lnactive lngredients)

acrylates/c10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, butylene glycol, cetearyl alcohol, ceteth-10 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, phenoxyethanol, steareth-21, water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

LidoGuard TM Cream - NDC - 85231-200-30 - Pain Relieving Cream - Topical Analgesic - 1.05 oz (30 g)

Carton Label

Manufactured For:

ViolaCare, Inc.

Parsippany, New Jersey, 07054

When Using This Product (When using this product)
  • do not use in or near the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase
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.

Active Ingredient                                           

Lidocaine HCl 4%.............................................Topical Analgesic

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:15.359604 · Updated: 2026-03-14T23:08:56.104871