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.

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Eclipse FA Topical Analgesic

​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. 54723-667-08

800-759-6876

packet

ECLIPSE TOPICAL ANALGESIC  FA
benzocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54723-668
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54723-668-081500 mg in 1 PACKET; Type 0: Not a Combination Product02/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/01/2016
Labeler - Sambria Pharmaceuticals, Inc. (078676259)
Establishment
NameAddressID/FEIBusiness Operations
A.I.G. Technologies, Inc.171837367manufacture(54723-668)
Establishment
NameAddressID/FEIBusiness Operations
JP Packaging LLC151369456repack(54723-668)

Revised: 8/2018
Document Id: 3bd75180-1c67-4c4f-9cd5-fa2581cb30fd
Set id: b03f91cd-9da2-4cbe-ad12-c98c1fe07641
Version: 2
Effective Time: 20180806
 
Sambria Pharmaceuticals, Inc.