Eclipse Topical Analgesic LL: Package Insert and Label Information

ECLIPSE TOPICAL ANALGESIC LL- tetracaine hydrochloride cream
Sambria Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

​Active Ingredients

Tetracaine HCL 2.0% w/w

​Purpose

External Analgesic

​Uses

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

​For external use only

Avoid contact with eyes

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

​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.

​Keep out of reach of children

• If product is swallowed, get medical help or contact a Poison Control Center right away.

​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. Apply in a circular motion for 30 to 60 seconds.

​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

​Other Information

Protect this product from excessive heat and direct sun.

​Questions or Comments?

FDA Registered: NDC No. 54723-669-05

800-759-6876

packet
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ECLIPSE TOPICAL ANALGESIC LL
tetracaine hcl cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54723-669
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TETRACAINE HYDROCHLORIDE (TETRACAINE) TETRACAINE HYDROCHLORIDE 20 mg in 1000 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54723-669-05 5 mg in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 05/01/2017
Labeler — Sambria Pharmaceuticals, Inc. (078676259)
Establishment
Name Address ID/FEI Operations
A.I.G. Technologies, Inc. 171837367 manufacture (54723-669)
Establishment
Name Address ID/FEI Operations
JP Packaging LLC 151369456 repack (54723-669)

Revised: 08/2018 Sambria Pharmaceuticals, Inc.

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