drug facts - dg health maximum strength pain relieving cleansing

drug facts - dg health maximum strength pain relieving cleansing
SPL v3
SPL
SPL Set ID 64f69315-77a3-49dc-940d-efd7a29c6645
Route
topical
Published
Effective Date 2021-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (1.3 mg)
Inactive Ingredients
chlorphenesin edetate disodium glycerin nonoxynol-9 phenoxyethanol propylene glycol water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-02-11

Purpose

Benzalkonium Cl – First Aid Antiseptic Lidocaine HCl – Pain Relieving Spray

Description

Benzalkonium Cl 0.13% Lidocaine HCl 4%


Medication Information

Warnings

For external use only

Uses

first aid to help prevent bacterial contamination or skin infection, and for temporary relief of pain and itching associated with minor:

  • cuts
  • scrapes
  • burns
  • sunburn
  • skin irritations
Purpose

Benzalkonium Cl – First Aid Antiseptic

Lidocaine HCl – Pain Relieving Spray

Directions
  • adults and children 2 years and older: clean the affected area; spray a small amount on the area 1-3 times daily; may be covered with a sterile bandage (let dry first)
  • children under 2 years: ask a doctor
Inactive Ingredients

chlorphenesin, edetate disodium, fragrance, glycerin, nonoxynol 9, phenoxyethanol, propylene glycol, purified water

Description

Benzalkonium Cl 0.13% Lidocaine HCl 4%

Principal Display Panel
Questions

888-309-9030

Active Ingredients

Benzalkonium Cl 0.13%

Lidocaine HCl 4%

When Using This Product
  • do not use in or near the eyes
  • do not apply over large areas of the body or in large quantities
  • do not apply over raw surfaces or blistered areas
Other Safety Information
  • store at room temperature
  • avoid excessive heat
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
Keep Out of Reach of Children.

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

Ask A Doctor Before Use If You Have
  • deep or puncture wounds
  • animal bites
  • serious burns
Package/label Principal Display Panel

Structured Label Content

Warnings

For external use only

Uses

first aid to help prevent bacterial contamination or skin infection, and for temporary relief of pain and itching associated with minor:

  • cuts
  • scrapes
  • burns
  • sunburn
  • skin irritations
Purpose

Benzalkonium Cl – First Aid Antiseptic

Lidocaine HCl – Pain Relieving Spray

Directions
  • adults and children 2 years and older: clean the affected area; spray a small amount on the area 1-3 times daily; may be covered with a sterile bandage (let dry first)
  • children under 2 years: ask a doctor
Inactive Ingredients (Inactive ingredients)

chlorphenesin, edetate disodium, fragrance, glycerin, nonoxynol 9, phenoxyethanol, propylene glycol, purified water

Principal Display Panel
Questions

888-309-9030

Active Ingredients (Active ingredients)

Benzalkonium Cl 0.13%

Lidocaine HCl 4%

When Using This Product (When using this product)
  • do not use in or near the eyes
  • do not apply over large areas of the body or in large quantities
  • do not apply over raw surfaces or blistered areas
Other Safety Information
  • store at room temperature
  • avoid excessive heat
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
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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep or puncture wounds
  • animal bites
  • serious burns
Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data


Raw Label Data

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