eclipse topical anesthetic

eclipse topical anesthetic
SPL v2
SPL
SPL Set ID ed3d5248-f054-44a4-882d-a3e3b6d694e9
Route
topical
Published
Effective Date 2019-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
water arnica montana flower c13-14 isoparaffin sodium chondroitin sulfate (porcine; 5500 mw) emu oil diethylene glycol monoethyl ether ethylhexylglycerin glucosamine sulfate isopropyl palmitate laureth-7 melaleuca alternifolia leaf dimethyl sulfone phenoxyethanol polyacrylamide (10000 mw) propylene glycol stearic acid trolamine

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2017-05-03

Purpose

External Analgesic

Description

Lidocaine HCL 4.00% w/w


Medication Information

Warnings

​For external use only

​Avoid contact with eyes

Uses

For temporary relief of pain and itching due to minor skin irritation.

Purpose

External Analgesic

Directions

For adults and children two-years or older: Apply to affected area not more than 3 or 4 times daily.  Children under 2 years of age: consult a physician.  Apply in a circular motion for 30 to 60 seconds.

Inactive Ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chrondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexyglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine.

Description

Lidocaine HCL 4.00% 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 a doctor if

• Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within 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 Ingredient

Lidocaine HCL 4.00% w/w

​other Information

Protect this product from excessive heat and direct sun.

​questions Or Comments?

FDA Registered: NDC No. 54723-667-05

800-759-6876


Structured Label Content

Warnings

​For external use only

​Avoid contact with eyes

Uses

For temporary relief of pain and itching due to minor skin irritation.

Purpose

External Analgesic

Directions

For adults and children two-years or older: Apply to affected area not more than 3 or 4 times daily.  Children under 2 years of age: consult a physician.  Apply in a circular motion for 30 to 60 seconds.

Inactive Ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chrondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexyglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine.

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 a doctor if

• Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within 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 Ingredient

Lidocaine HCL 4.00% w/w

​other Information (​Other Information)

Protect this product from excessive heat and direct sun.

​questions Or Comments? (​Questions or Comments?)

FDA Registered: NDC No. 54723-667-05

800-759-6876


Advanced Ingredient Data


Raw Label Data

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