Eclipse Topical Anesthetic (Lidocaine Hydrochloride) Cream [Sambria Pharmaceuticals] -

ECLIPSE TOPICAL ANESTHETIC (LIDOCAINE HYDROCHLORIDE) CREAM [SAMBRIA PHARMACEUTICALS]
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NDC	54723-667-05
Set ID	ed3d5248-f054-44a4-882d-a3e3b6d694e9
Category	HUMAN OTC DRUG LABEL
Packager	Sambria Pharmaceuticals
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART348

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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

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

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 30 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. 54723-667-05

800-759-6876
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ECLIPSE TOPICAL ANESTHETIC
lidocaine hydrochloride cream

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)
EMU OIL (UNII: 344821WD61)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
LAURETH-7 (UNII: Z95S6G8201)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54723-667-05	0.005 g in 1 PACKET; Type 0: Not a Combination Product	05/03/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/03/2017

Labeler - Sambria Pharmaceuticals (078676259)

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

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

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