ECLIPSE TOPICAL ANESTHETIC- lidocaine hcl 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.

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Eclipse Topical Anesthetic

Drug Facts

Active Ingredient

Lidocaine HCl (4.00%)

Purpose

Local Anesthetic

Indications:

For temporary relief of pain associated with minor burns, minor cuts, scrapes, insect bites, or skin irritations.

Warnings:

- For external use only.

- Avoid contact with eyes.

- Do not apply to open wounds or damaged skin.

- If symptoms persists for more than seven days, discontinue use and consult physician.

Keep out of reach of children. If swallowed, consult physician.

- Do not use bandage tightly.

If pregnant or breast feeding,

contact physician.

Directions:

Apply directly to affected area. Do not use more than four times per day. Children under two-years of age: consult a physician.

Inactive Ingredients:

Aqua (Deionized Water), Arnica Montana Extract, C13-14 Isoparaffin, Chrondroitin Sulfate, Emu Oil, Ethoxydiglyol, Ethylhexylglycerin, G;lucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine.

Product Label

BoxLabel

ECLIPSE TOPICAL ANESTHETIC
lidocaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54723-634
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	40 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA (UNII: O80TY208ZW)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
EMU OIL (UNII: 344821WD61)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
LAURETH-7 (UNII: Z95S6G8201)
TEA TREE OIL (UNII: VIF565UC2G)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54723-634-00	3 mL in 1 PACKAGE; Type 0: Not a Combination Product	04/11/2015	06/12/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/11/2015	06/12/2017

Labeler - Sambria Pharmaceuticals, Inc. (078676259)

Revised: 6/2016

Document Id: 3b616317-1bcd-40c8-be2e-e111026e4656

Set id: a6791fa9-f306-4c6c-a4be-ef9cd94c6bae

Version: 4

Effective Time: 20160608

Sambria Pharmaceuticals, Inc.