Eclipse Topical Anesthetic: Package Insert and Label Information

ECLIPSE TOPICAL ANESTHETIC- lidocaine hydrochloride cream
Sambria Pharmaceuticals

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 Ingredient

Lidocaine HCL 4.00% 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

​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 than 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 or 4 times daily. Children under 2 years of age: consult a physician. Apply in a circular motion for 50 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.

​Other Information

Protect this product from excessive heat and direct sun.

​Questions or Comments?

FDA Registered: NDC No. 54723-667-10

800-759-6876

ECLIPSE TOPICAL ANESTHETIC lidocaine hydrochloride cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54723-667 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 40 mg in 1 g

Inactive Ingredients Ingredient Name Strength 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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54723-667-10 2 g in 1 PACKET None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/20/2015

Labeler — Sambria Pharmaceuticals (078676259)

Establishment
Name	Address	ID/FEI	Operations
A.I.G. Technologies, Inc.		171837367	manufacture (54723-667)

Establishment
Name	Address	ID/FEI	Operations
JP Packaging LLC		151369456	repack (54723-667)

Revised: 08/2018 Sambria Pharmaceuticals