SPL v4
SPL
SPL Set ID 69eef888-0044-485c-96a1-247ed1204858
Route
TOPICAL
Published
Effective Date 2023-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.005 g)
Inactive Ingredients
Butylated Hydroxytoluene Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Dimethicone 100 Edetate Disodium Glycerin Glyceryl Monostearate Hypromellose, Unspecified Isopropyl Myristate Methylparaben Sodium Propylparaben Sodium Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-02

Description

Benzalkonium Chloride 0.13% Lidocaine HCl 0.5%

Purpose

Benzalkonium Chloride 0.13%.....First Aid Antiseptic Lidocaine HCl 0.5%....................External Analgesic


Medication Information

Purpose

Benzalkonium Chloride 0.13%.....First Aid Antiseptic

Lidocaine HCl 0.5%....................External Analgesic

Description

Benzalkonium Chloride 0.13% Lidocaine HCl 0.5%

Uses

First aid to help prevent infection and for the temporary relief of pain and itching associated with minor cuts, scrapes and burns

Section 51945-4

Warnings

For external use only.

Do not use:

  • in the eyes or apply over large areas of the body
  • longer than 1 week unless directed by a doctor 
  • in large quantities, particularly over raw surfaces or blistered areas

Ask a doctor before use if you have:

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if:

  • condition worsens or clears up and occurs again within a few days
  • symptoms persists for more than 7 days
Directions

Adults and children 2 years of age and older:

  • clean the affected area
  • apply a small amount of this product not more than 3 times daily
  • may be covered with sterily bandage

Children under 2 years of age:do not use, consult a doctor

Active Ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Inactive Ingredients

Butylated Hydroxytoluene, Ceteareth 20, Cetostearyl Alcohol, Dimethicone (100 CST), Edetate Disodium Dihydrate, Glycerin, Glyceryl Monostearate, Hypromellose, Isopropyl Myristate, Methylparaben Sodium, Propylparaben Sodium, Purified Water

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


Structured Label Content

Uses

First aid to help prevent infection and for the temporary relief of pain and itching associated with minor cuts, scrapes and burns

Section 51945-4 (51945-4)

Purpose

Benzalkonium Chloride 0.13%.....First Aid Antiseptic

Lidocaine HCl 0.5%....................External Analgesic

Warnings

For external use only.

Do not use:

  • in the eyes or apply over large areas of the body
  • longer than 1 week unless directed by a doctor 
  • in large quantities, particularly over raw surfaces or blistered areas

Ask a doctor before use if you have:

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if:

  • condition worsens or clears up and occurs again within a few days
  • symptoms persists for more than 7 days
Directions

Adults and children 2 years of age and older:

  • clean the affected area
  • apply a small amount of this product not more than 3 times daily
  • may be covered with sterily bandage

Children under 2 years of age:do not use, consult a doctor

Active Ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Inactive Ingredients

Butylated Hydroxytoluene, Ceteareth 20, Cetostearyl Alcohol, Dimethicone (100 CST), Edetate Disodium Dihydrate, Glycerin, Glyceryl Monostearate, Hypromellose, Isopropyl Myristate, Methylparaben Sodium, Propylparaben Sodium, Purified Water

Pregnant Or Breast Feeding (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)

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away


Advanced Ingredient Data


Raw Label Data

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