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

Purpose

External Analgesic

Description

Lidocaine HCL 4.0% w/w


Medication Information

Warnings

​For external use only

Avoid contact with eyes

Uses

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

Purpose

External Analgesic

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.

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.

Description

Lidocaine HCL 4.0% w/w

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

Active Ingredients

Lidocaine HCL 4.0% w/w

Questions Or Comments?

954-492-9898


Structured Label Content

Warnings

​For external use only

Avoid contact with eyes

Uses

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

Purpose

External Analgesic

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.

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.

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)

Active Ingredients

Lidocaine HCL 4.0% w/w

Questions Or Comments? (Questions or Comments?)

954-492-9898


Advanced Ingredient Data


Raw Label Data

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