Astonea Lidocaine 4 % Cream

Astonea Lidocaine 4 % Cream
SPL v1
SPL
SPL Set ID 137d4608-8b39-f1bf-e063-6294a90a162c
Route
TOPICAL
Published
Effective Date 2024-03-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Isopropyl Alcohol Polysorbate 60 Trolamine Dimethicone Aloe Vera Leaf Cetostearyl Alcohol Ceteth-20 Phosphate Glycerin Phenoxyethanol Water Carbomer 940

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-12
Description

Lidocaine HCl 4%

Purpose

Lidocaine HCl - Topical anesthetic

Medication Information

Purpose

Lidocaine HCl - Topical anesthetic

Description

Lidocaine HCl 4%

Uses

temporarily relieves minor 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 swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor
Active Ingredients

Lidocaine HCl 4%

Inactive Ingredients

aloe vera leaf, carbomer 940, ceteth-20, cetostearyl alcohol, dimethicone, glycerin. glyceryl monostearate, isopropyl alcohol, petrolatum, phenoxyethanol, polysorbate 60, trolamine, water

When Using This Product
  • use only as directed
  • do not get into eyes
  • do not bandage tightly or apply external heat (such as a heating pad) 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 Poison Control Center (800-222-1222) right away.

Package/label Principal Display Panel

Structured Label Content

Uses

temporarily relieves minor 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 swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor
Active Ingredients (Active ingredients)

Lidocaine HCl 4%

Inactive Ingredients (Inactive ingredients)

aloe vera leaf, carbomer 940, ceteth-20, cetostearyl alcohol, dimethicone, glycerin. glyceryl monostearate, isopropyl alcohol, petrolatum, phenoxyethanol, polysorbate 60, trolamine, water

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 (such as a heating pad) 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 Poison Control Center (800-222-1222) right away.

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:51.786364 · Updated: 2026-03-14T23:02:39.250584