Natureplex™ Lidocaine 4%

Natureplex™ Lidocaine 4%
SPL v3
SPL
SPL Set ID 3ef32f80-7392-4a8c-b2c9-b58e4af61191
Route
TOPICAL
Published
Effective Date 2021-05-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.04 g)
Inactive Ingredients
Aloe Vera Leaf Sulisobenzone Caprylyl Glycol Cetyl Alcohol Dimethyl Sulfoxide Hexylene Glycol Tea Tree Oil Phenoxyethanol Potassium Sorbate Water Simmondsia Chinensis Seed Sodium Polyacrylate (8000 Mw) Stearic Acid Arginine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-03-15

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 28 G Tube Carton

Natureplex™

* Compare active ingredients to

Gold Bond® with 4% Lidocaine

Lidocaine 4%

Pain & Itch Relief Cream

NET WT. 1.0 Oz.(28g)


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 28 G Tube Carton (PRINCIPAL DISPLAY PANEL - 28 g Tube Carton)

Natureplex™

* Compare active ingredients to

Gold Bond® with 4% Lidocaine

Lidocaine 4%

Pain & Itch Relief Cream

NET WT. 1.0 Oz.(28g)


Advanced Ingredient Data


Raw Label Data

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