67e42947-3e05-c72c-e053-2991aa0adb99

SPL v1
SPL
SPL Set ID 67e42947-3e05-c72c-e053-2991aa0adb99
Route
topical
Published
Effective Date 2018-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (1 g) lidocaine (4 g)
Inactive Ingredients
isopropyl palmitate lecithin, soybean poloxamer 407 benzyl alcohol water polyglyceryl-4 stearate palm kernel oil polyglyceryl-4 oleate sodium hydroxide

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2018-04-01

Purpose

Topical analgesic

Description

Lidocaine 4% Menthol 1%


Medication Information

Warnings

For external use only

Uses

Temporarily relieves minor pain

Purpose

Topical analgesic

Directions

Adults and children over 12 years: Apply generously (about the thickness of a nickel) to the affected area as needed, not to exceed 3 applications in a 24 hour period. Children 12 years or younger: ask a doctor

Other Information

Store at 20-25ºC (68-77ºF)

Inactive Ingredients

benzyl alcohol, isopropyl palmitate, lecithin, palm kernel oil, poloxamer 407, polyglyceryl-4 esters, sodium hydroxide, water

Description

Lidocaine 4% Menthol 1%

Questions?

1-833-DYVE-BIO

Section 51945-4

Do Not Use

On large areas of the body or on cut, irritated or swollen skin

On puncture wounds

For more than one week without consulting a doctor

Active Ingredients

Lidocaine 4%

Menthol 1%

When Using This Product:

Use only as directed

Read and follow all direction and warnings on this carton

Do not allow contact with eyes

Do not bandage or apply local heat to the area of use

If Pregnant Or Breastfeeding,

ask a health professional before use

Stop Using and Ask A Doctor If

Condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children and Pets.

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


Structured Label Content

Warnings

For external use only

Uses

Temporarily relieves minor pain

Purpose

Topical analgesic

Directions

Adults and children over 12 years: Apply generously (about the thickness of a nickel) to the affected area as needed, not to exceed 3 applications in a 24 hour period. Children 12 years or younger: ask a doctor

Other Information (Other information)

Store at 20-25ºC (68-77ºF)

Inactive Ingredients (Inactive ingredients)

benzyl alcohol, isopropyl palmitate, lecithin, palm kernel oil, poloxamer 407, polyglyceryl-4 esters, sodium hydroxide, water

Questions?

1-833-DYVE-BIO

Section 51945-4 (51945-4)

Do Not Use (Do not use)

On large areas of the body or on cut, irritated or swollen skin

On puncture wounds

For more than one week without consulting a doctor

Active Ingredients

Lidocaine 4%

Menthol 1%

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

Use only as directed

Read and follow all direction and warnings on this carton

Do not allow contact with eyes

Do not bandage or apply local heat to the area of use

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use

Stop Using and Ask A Doctor If (Stop using and ask a doctor if)

Condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children and Pets. (Keep out of reach of children and pets.)

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


Advanced Ingredient Data


Raw Label Data

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