Proplex Lidocaine 4%

Proplex Lidocaine 4%
SPL v2
SPL
SPL Set ID 9975050c-8a84-4265-960f-a13729922764
Route
TOPICAL
Published
Effective Date 2021-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Aloe Vera Leaf Arginine Sulisobenzone Cetyl Alcohol Dimethyl Sulfoxide Angophora Costata Whole Melaleuca Alternifolia Leaf Water Jojoba Oil Sodium Polyacrylate (2500000 Mw) Stearic Acid Caprylyl Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-03-18

Description

Drug Facts

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Drug Facts

Use

for the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Section 50570-1

Do not use in large quantities, particularly over raw surfaces or blistered areas.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

For external use only.

Avoid contact with eyes.

Not for prolonged use.

Directions

Adults and children 2 years of age and older:

  • apply to affected area not more than 3 to 4 times daily

Children under 2 years of age:

  • consult a doctor
Active Ingredient

Lidocaine 4%

Other Information
  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
Inactive Ingredients

Aloe barbadensis leaf juice, arginine, benzophenone-4, caprylyl glycol, cetyl alcohol, dimethyl sulfoxide, hexylene glycol, melaleuca alternifolia (tea tree) leaf oil, phenoxyethanol, potassium sorbate, purified water, simmondsia chinensis (jojoba) seed oil, sodium polyacrylate, stearic acid

Questions Or Comments?

866-323-0107 or www.natureplex.com

Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occurs again within a few days
  • rash or irritation develops, persists, or increases
Principal Display Panel 85 G Tube Carton

NDC # 67234-052-01

lidocaine

4%

  • Numbs away pain
  • No irritation, no burning

    & non-greasy
  • With Tea Tree Oil

NET WT. 3 oz (85 g)

PROPLEX


Structured Label Content

Use

for the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Section 50570-1 (50570-1)

Do not use in large quantities, particularly over raw surfaces or blistered areas.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Topical analgesic

Warnings

For external use only.

Avoid contact with eyes.

Not for prolonged use.

Directions

Adults and children 2 years of age and older:

  • apply to affected area not more than 3 to 4 times daily

Children under 2 years of age:

  • consult a doctor
Active Ingredient (Active ingredient)

Lidocaine 4%

Other Information (Other information)
  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
Inactive Ingredients (Inactive ingredients)

Aloe barbadensis leaf juice, arginine, benzophenone-4, caprylyl glycol, cetyl alcohol, dimethyl sulfoxide, hexylene glycol, melaleuca alternifolia (tea tree) leaf oil, phenoxyethanol, potassium sorbate, purified water, simmondsia chinensis (jojoba) seed oil, sodium polyacrylate, stearic acid

Questions Or Comments? (Questions or comments?)

866-323-0107 or www.natureplex.com

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 occurs again within a few days
  • rash or irritation develops, persists, or increases
Principal Display Panel 85 G Tube Carton (PRINCIPAL DISPLAY PANEL - 85 g Tube Carton)

NDC # 67234-052-01

lidocaine

4%

  • Numbs away pain
  • No irritation, no burning

    & non-greasy
  • With Tea Tree Oil

NET WT. 3 oz (85 g)

PROPLEX


Advanced Ingredient Data


Raw Label Data

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