046db8f1-3042-44ae-92b7-d467177bac65

SPL v1
SPL
SPL Set ID 046db8f1-3042-44ae-92b7-d467177bac65
Route
topical
Published
Effective Date 2024-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (4 g)
Inactive Ingredients
acyclovir polyacrylic acid (450000 mw) dihydroxyaluminum aminoacetate glycerin water dmdm hydantoin edetic acid sodium polyacrylate (8000 mw) sodium acryloyldimethyltaurate-acrylamide copolymer (1:1; 90000-150000 mpa.s) tartaric acid titanium dioxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-03-06

Purpose

Topical analgesic

Storage and Handling

Store between 15-30℃(59-86℉) keep away from children

Description

Lidocaine 4 % w/w.


Medication Information

Warnings

For external use only.

Purpose

Topical analgesic

Directions

Adults and children 12 years of age and older:

 Clean and dry affected area

 Remove film from patch and apply to the skin

 Apply 1 patch at a time to the 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

Storage and Handling

Store between 15-30℃(59-86℉) keep away from children

Inactive Ingredients

Acyclovir, Dihydroxyaluminum aminoacetetel, DMDM hydantoin, Edetic acid, Glycerin, Polyacrylic acid, Sodium polyacrylate, Sodium Acryloyldimethyltaurate-acrylamide copolymer, Tartaric acid, Titanium dioxide, Wate

Description

Lidocaine 4 % w/w.

Use

Temporary relief of minor pain.

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

Active Ingredient(s)

Lidocaine 4 % w/w.

When Using This Product:

 Use only as directed

 Do not bandage tightly

 Avoid contact with eyes, mucous membranes or rashes

Keep Out of Reach of Children

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

Stop Use and Ask A Doctor If:

 Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering

 Condition worsens

 Symptoms persist for more than 7 days

 Symptoms clear up and occur again within a few days

If pregnant or breastfeeding, ask a health professional before use.

Package Label Principal Display Panel


Structured Label Content

Warnings

For external use only.

Purpose

Topical analgesic

Directions

Adults and children 12 years of age and older:

 Clean and dry affected area

 Remove film from patch and apply to the skin

 Apply 1 patch at a time to the 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

Storage and Handling (STORAGE AND HANDLING)

Store between 15-30℃(59-86℉) keep away from children

Inactive Ingredients (Inactive ingredients)

Acyclovir, Dihydroxyaluminum aminoacetetel, DMDM hydantoin, Edetic acid, Glycerin, Polyacrylic acid, Sodium polyacrylate, Sodium Acryloyldimethyltaurate-acrylamide copolymer, Tartaric acid, Titanium dioxide, Wate

Use

Temporary relief of minor pain.

Do Not Use (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

Active Ingredient(s)

Lidocaine 4 % w/w.

When Using This Product: (When using this product:)

 Use only as directed

 Do not bandage tightly

 Avoid contact with eyes, mucous membranes or rashes

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.

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

 Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering

 Condition worsens

 Symptoms persist for more than 7 days

 Symptoms clear up and occur again within a few days

If pregnant or breastfeeding, ask a health professional before use.

Package Label Principal Display Panel (Package Label - Principal Display Panel)


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