Simplicity Desensitizing Gel

Simplicity Desensitizing Gel
SPL v4
SPL
SPL Set ID 8660021c-69c4-49c3-959d-2182c581aa0f
Route
TOPICAL
Published
Effective Date 2014-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Carbomer Homopolymer Type C Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-07-15

Description

Lidocaine 4% w/w

Purpose

Topical anesthetic


Medication Information

Purpose



Topical anesthetic

Description

Lidocaine 4% w/w

Use:

temporarily relieves pain and itching due to:

  • minor cuts
  • minor scrapes
  • sunburn
  • minor skin irritations
  • minor burns
  • insect bites
Section 50567-7
  • do not use in or near the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas
Warnings:

For external use only.

Directions:
  • Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily.
  • Children under 2 years of age: Consult a doctor.
Other Information

Store at USP controlled room temperature 20-25 deg.C (68-77 deg.F).

Active Ingredient:

Lidocaine 4% w/w

Inactive Ingredients

Ag,carbomer 940, deionized water

Stop Use and Ask 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
Keep Out of Reach of Children.

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

Simplicity Desensitizing Gel, 1 Fl Oz/30ml (69109 004 30)


Structured Label Content

Use:

temporarily relieves pain and itching due to:

  • minor cuts
  • minor scrapes
  • sunburn
  • minor skin irritations
  • minor burns
  • insect bites
Section 50567-7 (50567-7)
  • do not use in or near the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas
Purpose



Topical anesthetic

Warnings:

For external use only.

Directions:
  • Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily.
  • Children under 2 years of age: Consult a doctor.
Other Information

Store at USP controlled room temperature 20-25 deg.C (68-77 deg.F).

Active Ingredient:

Lidocaine 4% w/w

Inactive Ingredients (Inactive ingredients)

Ag,carbomer 940, deionized water

Stop Use and Ask Doctor If (Stop use and ask 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
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.

Simplicity Desensitizing Gel, 1 Fl Oz/30ml (69109 004 30) (Simplicity Desensitizing Gel, 1 fl oz/30mL (69109-004-30))


Advanced Ingredient Data


Raw Label Data

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