Eclipse Topical Analgesic FA: Package Insert and Label Information

ECLIPSE TOPICAL ANALGESIC FA- benzocaine 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

Benzocaine 20.0% w/w

​Purpose

External Analgesic

​Uses

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

​Warnings

​For external use only

Avoid contact with eyes

​Stop use and ask 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 then 3 or 4 times daily. Children under 2 years of age: consult a physician.

​Inactive Ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Caprylic/Capric Triglyceride, Cetearetj-25, Chondroitin Sulfate, Diethylhexyl Sodium Sulfosuccinate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Isopropyl Palmitate, Laureth-7, Melaleuca alternifolia (Tea Tree) Leaf Oil, Methylfulfonylmenthane (MSM), Phenoxyethanol, Polyacrylamide, Polysorbate-20, Safflower Oil, Stearic Acid, Triethanolamine

​Other Information

Protect this product from excessive heat or direct sun.

​Questions or Comments?

FDA Registered: NDC No. 54723-668-03

800-759-6876

ECLIPSE TOPICAL ANALGESIC FA benzocaine cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54723-668 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (BENZOCAINE) BENZOCAINE 20 mg in 100 mg

Inactive Ingredients Ingredient Name Strength water ARNICA MONTANA FLOWER C13-14 ISOPARAFFIN MEDIUM-CHAIN TRIGLYCERIDES CETEARETH-25 CHONDROITIN SULFATE SODIUM (BOVINE) DOCUSATE SODIUM EMU OIL DIETHYLENE GLYCOL MONOETHYL ETHER ETHYLHEXYLGLYCERIN GLUCOSAMINE SULFATE GLYCERIN ISOPROPYL PALMITATE LAURETH-7 MELALEUCA ALTERNIFOLIA LEAF DIMETHYL SULFONE PHENOXYETHANOL POLYACRYLAMIDE (10000 MW) POLYSORBATE 20 SAFFLOWER OIL STEARIC ACID TROLAMINE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54723-668-03 3000 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 02/01/2016

Labeler — Sambria Pharmaceuticals, Inc. (078676259)

Establishment
Name	Address	ID/FEI	Operations
A.I.G. Technologies, Inc.		171837367	manufacture (54723-668)

Establishment
Name	Address	ID/FEI	Operations
JP Packaging LLC		151369456	repack (54723-668)

Revised: 08/2018 Sambria Pharmaceuticals, Inc.