Eclipse Topical Analgesic Fa (Benzocaine) Cream [Sambria Pharmaceuticals, Inc.] -

ECLIPSE TOPICAL ANALGESIC FA (BENZOCAINE) CREAM [SAMBRIA PHARMACEUTICALS, INC.]
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NDC	54723-668-03
Set ID	152fe0a3-521f-470b-bcd1-cf9a57da996e
Category	HUMAN OTC DRUG LABEL
Packager	Sambria Pharmaceuticals, Inc.
Generic Name
Product Class
Product Number
Application Number	PART348

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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

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

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
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ECLIPSE TOPICAL ANALGESIC FA
benzocaine cream

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 mg in 100 mg

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETEARETH-25 (UNII: 8FA93U5T67)
CHONDROITIN SULFATE SODIUM (BOVINE) (UNII: 8QTV3DTT8W)
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
EMU OIL (UNII: 344821WD61)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCERIN (UNII: PDC6A3C0OX)
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)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SAFFLOWER OIL (UNII: 65UEH262IS)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54723-668-03	3000 mg in 1 PACKET; Type 0: Not a Combination Product	02/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	02/01/2016

Labeler - Sambria Pharmaceuticals, Inc. (078676259)

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

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

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