eclipse ll topical analgesic

eclipse ll topical analgesic
SPL v2
SPL
SPL Set ID be19e1aa-0dae-4534-8cff-2af13347e963
Route
topical
Published
Effective Date 2019-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
tetracaine (20 mg)
Inactive Ingredients
water arnica montana flower c13-14 isoparaffin chondroitin sulfate sodium (bovine) emu oil diethylene glycol monoethyl ether ethylhexylglycerin glucosamine sulfate isopropyl palmitate laureth-7 melaleuca alternifolia leaf dimethyl sulfone phenoxyethanol propylene glycol stearic acid trolamine

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2016-02-01

Purpose

External Analgesic

Description

Tetracaine HCL     2.0% w/w


Medication Information

Warnings and Precautions

​For external use only

Avoid contact with eyes

Purpose

External Analgesic

Description

Tetracaine HCL     2.0% 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 a doctor if

• Condition worsens, or if symptoms persist for more then 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

​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 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

Tetracaine HCL     2.0% w/w

​inactive Ingredients

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

​questions Or Comments?

FDA Registered: NDC No. 54723-667-03

800-759-6876


Structured Label Content

Warnings and Precautions (34071-1)

​For external use only

Avoid contact with eyes

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 then 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)

​uses (​Uses)

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

​purpose (​Purpose)

External Analgesic

​directions (​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 (​Other Information)

Protect this product from excessive heat and direct sun.

​active Ingredients (​Active Ingredients)

Tetracaine HCL     2.0% w/w

​inactive Ingredients (​Inactive Ingredients)

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

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

FDA Registered: NDC No. 54723-667-03

800-759-6876


Advanced Ingredient Data


Raw Label Data

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