Universal Heat Patch Pain Relief

Universal Heat Patch Pain Relief
SPL v2
SPL
SPL Set ID b132a4f2-1b1f-4e80-a183-f9add449065f
Route
TOPICAL
Published
Effective Date 2023-06-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.04 g)
Inactive Ingredients
Glycerin Sodium Polyacrylate (2500000 Mw) Dihydroxyaluminum Aminoacetate Anhydrous Edetate Disodium Kaolin Titanium Dioxide Polysorbate 80 Propylene Glycol Tartaric Acid Polyacrylic Acid (250000 Mw) Povidone K90 Methylparaben Propylparaben Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-30

Description

Lidocaine 4%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4%

Uses:

For temporary relief of pain

Section 42229-5

HOT & COLD RELIEF

FAST ACTING

PAIN RELIEF

DESENSITIZE AGGRAVATED NERVES

  • Back
  • Neck
  • Shoulders
  • Knees & Elbows

APPLY FOR 8 HOURS

CONTAINS FIVE 5.5"X3.94" INDIVIDUALLY PACKED PATCHES

HOW TO APPLY

1. Remove patch from outer package

2. Partially peel back protective film

3. Place on affected area

4. Remove remaining film while pressing patch to skin

USE COLD

For temporary relief of pain associated with:

  • Swelling
  • Sprains & Strains
  • Bumps & Bruises
  • Sports injury
  • Toothache
  • Fever

USE HOT

For temporary relief of pain associated with:

  • Muscle aches
  • Mild Arthritis
  • Menstrual cramps
  • Joint stiffness
  • Sports injury

Mfd and Distributed By:

Universal Distribution Center

96 Distribution Boulevard, Edison, NJ 08817

www.universaldc.com

Made in P.R.C

Section 50565-1

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

Warnings

For external use only

Do not use: • More than 1 patch at a time • On wounds or damaged skin • With a heating pad • If you are allergic to any ingredients of this product

When using this product: • Use only as directed • Avoid contact with the eyes, mucous membranes or rashes • Do not bandage tightly

Stop use and ask a doctor if: • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering

• Conditions worsen

• Symptoms persists for more than 7 days

• Symptoms clear up and occur again within a few days

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

Packaging

Directions

Adult and Children 12 years of age and over:

  • Clean and dry affected area
  • Remove film from patch and apply to the skin (see illustration)
  • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • Remove patch from the skin after at most 8-hour application

Children under 12 years of age: Consult a doctor

Active Ingredient

Lidocaine 4%

Other Information
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
Inactive Ingredients

Glycerin, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Kaolin, Titanium Dioxide, Polysorbate 80, Propylene Glycol, Tartaric Acid, Polyacrylic Acid, Polyvinylpyrrolidone K90, Methylparaben, Propylparaben, Water


Structured Label Content

Uses:

For temporary relief of pain

Section 42229-5 (42229-5)

HOT & COLD RELIEF

FAST ACTING

PAIN RELIEF

DESENSITIZE AGGRAVATED NERVES

  • Back
  • Neck
  • Shoulders
  • Knees & Elbows

APPLY FOR 8 HOURS

CONTAINS FIVE 5.5"X3.94" INDIVIDUALLY PACKED PATCHES

HOW TO APPLY

1. Remove patch from outer package

2. Partially peel back protective film

3. Place on affected area

4. Remove remaining film while pressing patch to skin

USE COLD

For temporary relief of pain associated with:

  • Swelling
  • Sprains & Strains
  • Bumps & Bruises
  • Sports injury
  • Toothache
  • Fever

USE HOT

For temporary relief of pain associated with:

  • Muscle aches
  • Mild Arthritis
  • Menstrual cramps
  • Joint stiffness
  • Sports injury

Mfd and Distributed By:

Universal Distribution Center

96 Distribution Boulevard, Edison, NJ 08817

www.universaldc.com

Made in P.R.C

Section 50565-1 (50565-1)

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

Purpose

Topical anesthetic

Warnings

For external use only

Do not use: • More than 1 patch at a time • On wounds or damaged skin • With a heating pad • If you are allergic to any ingredients of this product

When using this product: • Use only as directed • Avoid contact with the eyes, mucous membranes or rashes • Do not bandage tightly

Stop use and ask a doctor if: • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering

• Conditions worsen

• Symptoms persists for more than 7 days

• Symptoms clear up and occur again within a few days

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

Packaging

Directions

Adult and Children 12 years of age and over:

  • Clean and dry affected area
  • Remove film from patch and apply to the skin (see illustration)
  • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • Remove patch from the skin after at most 8-hour application

Children under 12 years of age: Consult a doctor

Active Ingredient (Active ingredient)

Lidocaine 4%

Other Information (Other information)
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
Inactive Ingredients (Inactive ingredients)

Glycerin, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Kaolin, Titanium Dioxide, Polysorbate 80, Propylene Glycol, Tartaric Acid, Polyacrylic Acid, Polyvinylpyrrolidone K90, Methylparaben, Propylparaben, Water


Advanced Ingredient Data


Raw Label Data

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