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Eclipse Topical Analgesic FA by Sambria Pharmaceuticals, Inc.

Medically reviewed on Jun 18, 2018

Dosage form: cream
Ingredients: BENZOCAINE 20mg in 100mg
Labeler: Sambria Pharmaceuticals, Inc.
NDC Code: 54723-668

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.

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

ECLIPSE TOPICAL ANALGESIC  FA
benzocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54723-668
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE20 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
water 
ARNICA MONTANA FLOWER 
C13-14 ISOPARAFFIN 
MEDIUM-CHAIN TRIGLYCERIDES 
CETEARETH-25 
CHONDROITIN SULFATE SODIUM (BOVINE) 
DOCUSATE SODIUM 
EMU OIL 
DIETHYLENE GLYCOL MONOETHYL ETHER 
ETHYLHEXYLGLYCERIN 
GLUCOSAMINE SULFATE 
GLYCERIN 
ISOPROPYL PALMITATE 
LAURETH-7 
MELALEUCA ALTERNIFOLIA LEAF 
DIMETHYL SULFONE 
PHENOXYETHANOL 
POLYACRYLAMIDE (10000 MW) 
POLYSORBATE 20 
SAFFLOWER OIL 
STEARIC ACID 
TROLAMINE 
Packaging
#Item CodePackage Description
1NDC:54723-668-081500 mg in 1 PACKET
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/FEIOperations
A.I.G. Technologies, Inc.171837367manufacture(54723-668)
Establishment
NameAddressID/FEIOperations
American Flexpack, Inc.019914600label(54723-668), pack(54723-668)

 
Sambria Pharmaceuticals, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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