Blister Defense Patch

Blister Defense Patch
SPL v1
SPL
SPL Set ID 22cbb664-b659-3beb-e063-6394a90a9dab
Route
TOPICAL
Published
Effective Date 2024-08-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 mg)
Inactive Ingredients
Ethylene-vinyl Acetate Copolymer (15% Vinyl Acetate)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-16

Description

Lidocaine 4%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Lidocaine 4%

Uses
  • For the temporary relief of pain
Warnings

For external use only

Directions
  • Adults and children 12 years and over: clean and dry affected area
  • peel film from patch and plastic liner and apply to the skin
  • apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • wash hands after applying patch
  • remove patch from the skin after at most 8 hours application
  • Children under 12 years of age: do not use, consult a physician before use.
Do Not Use
  • large quantities
  • on raw surfaces, blistered areas, wounds or damaged skin
  • if you are allergic to any ingredients of this product
Active Ingredient

Lidocaine 4%

Other Information
  • Store at room temperature
  • keep away from excessive heat
  • do not exceed 100 oF (38 oC)
Inactive Ingredients

acrylic adhesive, polyester fabric

Principal Display Panel

CARE SCIENCE

4% LIDOCAINE PAIN RELIEF

BLISTER DEFENSE PATCH

DESIGNED FOR TOES AND HEELS

LASTS UP TO 8 HOURS

Maximum OTC Strength

  • For temporary relief of pain associated with pressure and friction
  • Lidocaine in adhesive temporarily numbs pain

Flexible Fabric

  • Covers and Protects Skin
  • Durable, Breathable
  • Thin and Flexible Fabric Easily conforms to Skin

When Using This Product
  • do not use other topical products
  • do not allow contact with eyes or mucous membranes
  • apply only to clean, dry, and untreated skin
  • use only as directed
Stop Use and Ask A Doctor If
  • skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
If Pregnant Or Breast Feeding

ask a health care professional before use.

Keep Out of Reach of Children.

If put in mouth, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Structured Label Content

Uses
  • For the temporary relief of pain
Purpose

Topical Analgesic

Warnings

For external use only

Directions
  • Adults and children 12 years and over: clean and dry affected area
  • peel film from patch and plastic liner and apply to the skin
  • apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • wash hands after applying patch
  • remove patch from the skin after at most 8 hours application
  • Children under 12 years of age: do not use, consult a physician before use.
Do Not Use (Do not use)
  • large quantities
  • on raw surfaces, blistered areas, wounds or damaged skin
  • if you are allergic to any ingredients of this product
Active Ingredient (Active ingredient)

Lidocaine 4%

Other Information (Other information)
  • Store at room temperature
  • keep away from excessive heat
  • do not exceed 100 oF (38 oC)
Inactive Ingredients (Inactive ingredients)

acrylic adhesive, polyester fabric

Principal Display Panel

CARE SCIENCE

4% LIDOCAINE PAIN RELIEF

BLISTER DEFENSE PATCH

DESIGNED FOR TOES AND HEELS

LASTS UP TO 8 HOURS

Maximum OTC Strength

  • For temporary relief of pain associated with pressure and friction
  • Lidocaine in adhesive temporarily numbs pain

Flexible Fabric

  • Covers and Protects Skin
  • Durable, Breathable
  • Thin and Flexible Fabric Easily conforms to Skin

When Using This Product (When using this product)
  • do not use other topical products
  • do not allow contact with eyes or mucous membranes
  • apply only to clean, dry, and untreated skin
  • use only as directed
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health care professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If put in mouth, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Advanced Ingredient Data


Raw Label Data

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