derma numb pain relieving spray

derma numb pain relieving spray
SPL v9
SPL
SPL Set ID 710991ae-8f82-4893-93a7-0ef3f815d132
Route
topical
Published
Effective Date 2024-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
water propylene glycol achillea millefolium yucca schidigera citric acid monohydrate sodium metabisulfite 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, Caprylyl Glycol, Citric Acid, Disodium EDTA, Methylisothiazolinone, Propylene Glycol, Schidigera (Yucca) Root Extract, Sodium Metabisulfate, 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, Caprylyl Glycol, Citric Acid, Disodium EDTA, Methylisothiazolinone, Propylene Glycol, Schidigera (Yucca) Root Extract, Sodium Metabisulfate, 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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