Dermanumb Gel

Dermanumb Gel
SPL v9
SPL
SPL Set ID 0ea46890-45c3-4732-bc47-227f7c67daf1
Route
TOPICAL
Published
Effective Date 2024-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Water Alcohol Aloe Vera Leaf Propylene Glycol Trolamine Carbomer Interpolymer Type B (allyl Pentaerythritol Crosslinked) Menthol Achillea Millefolium Yucca Schidigera Glycerin Caprylyl Glycol Edetate Disodium Methylisothiazolinone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-07-01

Description

Lidocaine HCL 4.0% w/w

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Lidocaine HCL 4.0% w/w

Uses

For temporary relief of pain and itching associated with minor cuts or minor skin irritations.

Section 50565-1

​Keep out of reach of children

• If product is swallowed, get medical help or contact a poison control center right away.

Section 50566-9

​Stop use and ask doctor if

​• Condition worsens, or if symptoms persist for more then 7 days or clear up and occur again with a few days.  Discontinue use.

Section 50570-1

Do not use ​in large quantities, particularly over raw surfaces or blistered areas

Section 51945-4

Warnings

​For external use only

Avoid contact with eyes

Directions

For adults and children two-years or older: Apply to affected area not more than 3 to 4 times daily.  Children under 2 years of age: consult a physician.

Other Information

Protect this product from excessive heat and direct sun.

Active Ingredients

Lidocaine HCL 4.0% w/w

Inactive Ingredients

Achillea Millegolium (Yarrow) Extract, Alcohol SDA-40, Aloe Barbadensis Leaf Extract, Capryly Glycol, Carbomer, Disodium EDTA, Glycerin, Menthol, Methylisothiazolinone, Propylene Glycol, Schidigera (Yucca) Root Extract, Triethanolamine, Water.

Questions Or Comments?

954-492-9898


Structured Label Content

Uses

For temporary relief of pain and itching associated with minor cuts or minor skin irritations.

Section 50565-1 (50565-1)

​Keep out of reach of children

• If product is swallowed, get medical help or contact a poison control center right away.

Section 50566-9 (50566-9)

​Stop use and ask doctor if

​• Condition worsens, or if symptoms persist for more then 7 days or clear up and occur again with a few days.  Discontinue use.

Section 50570-1 (50570-1)

Do not use ​in large quantities, particularly over raw surfaces or blistered areas

Section 51945-4 (51945-4)

Purpose

External Analgesic

Warnings

​For external use only

Avoid contact with eyes

Directions

For adults and children two-years or older: Apply to affected area not more than 3 to 4 times daily.  Children under 2 years of age: consult a physician.

Other Information

Protect this product from excessive heat and direct sun.

Active Ingredients

Lidocaine HCL 4.0% w/w

Inactive Ingredients

Achillea Millegolium (Yarrow) Extract, Alcohol SDA-40, Aloe Barbadensis Leaf Extract, Capryly Glycol, Carbomer, Disodium EDTA, Glycerin, Menthol, Methylisothiazolinone, Propylene Glycol, Schidigera (Yucca) Root Extract, Triethanolamine, Water.

Questions Or Comments? (Questions or Comments?)

954-492-9898


Advanced Ingredient Data


Raw Label Data

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