drug facts

drug facts
SPL v7
SPL
SPL Set ID 0578fbcb-875a-4606-acde-dcecb29756e6
Route
topical
Published
Effective Date 2020-07-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (1.2 g)
Inactive Ingredients
propylene glycol butyl ether tocopheryl retinoate water benzyl alcohol carbomer homopolymer, unspecified type lecithin, soybean

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2017-10-12

Purpose

Topical Anesthetic

Description

Lidocaine 4% w/w


Medication Information

Warnings

For external use only

Uses

Temporarily relieves pain and itching due to

  • insect bites
  • minor burns
  • minor cuts
  • minor scrapes
  • minor skin irritations
  • sunburn
Purpose

Topical Anesthetic

Directions
  • Adults and children 2 years and older: Apply externally to the affected area up to 3 to 4 times a day
  • Children under 2 years: Consult a doctor
Other Information
  • May be applied under occlusive dressing. 
  • Store at 25 ̊C (77 ̊F);
  • excursions permitted to 15°C -30°C (59°F - 86°F) [see USP Controlled Room Temperature].
Inactive Ingredients

Benzyl Alcohol, Carbopol, Lecithin(Soybean), Propylene Glycol, Tocopheryl Acetate, Water.

Description

Lidocaine 4% w/w

Principal Display Panel

NDC 69903-003-30

Water-based, Hypoallergenic and Fast Penetrating Topical Pain Relief and Anti-Itch Formula

Apply to the skin to relieve pain

FOR EXTERNAL USE ONLY

Dr. Numb

TOPICAL ANESTHETIC CREAM

Lidocaine 4% Cream -  Topical Anesthetic

30g

Active Ingredient

Lidocaine 4% w/w

Question Or Comments

Contact our dedicated Customer Care at +1(877) 786 2001 or email us at [email protected]

When Using This Product
  • avoid contact with the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas
Keep Our of Reach of Children

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

Stop the Use and Consult Doctor If
  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase

Structured Label Content

Warnings

For external use only

Uses

Temporarily relieves pain and itching due to

  • insect bites
  • minor burns
  • minor cuts
  • minor scrapes
  • minor skin irritations
  • sunburn
Purpose

Topical Anesthetic

Directions
  • Adults and children 2 years and older: Apply externally to the affected area up to 3 to 4 times a day
  • Children under 2 years: Consult a doctor
Other Information
  • May be applied under occlusive dressing. 
  • Store at 25 ̊C (77 ̊F);
  • excursions permitted to 15°C -30°C (59°F - 86°F) [see USP Controlled Room Temperature].
Inactive Ingredients

Benzyl Alcohol, Carbopol, Lecithin(Soybean), Propylene Glycol, Tocopheryl Acetate, Water.

Principal Display Panel

NDC 69903-003-30

Water-based, Hypoallergenic and Fast Penetrating Topical Pain Relief and Anti-Itch Formula

Apply to the skin to relieve pain

FOR EXTERNAL USE ONLY

Dr. Numb

TOPICAL ANESTHETIC CREAM

Lidocaine 4% Cream -  Topical Anesthetic

30g

Active Ingredient (Active ingredient)

Lidocaine 4% w/w

Question Or Comments (Question or Comments)

Contact our dedicated Customer Care at +1(877) 786 2001 or email us at [email protected]

When Using This Product (When using this product)
  • avoid contact with the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas
Keep Our of Reach of Children (KEEP OUR OF REACH OF CHILDREN)

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

Stop the Use and Consult Doctor If (Stop the use and consult doctor if)
  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase

Advanced Ingredient Data


Raw Label Data

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