Label: ECLIPSE TOPICAL ANALGESIC FA- benzocaine cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated August 6, 2018

If you are a consumer or patient please visit this version.

View All Sections
  • ​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. 54723-667-08

    800-759-6876

  • PRINCIPAL DISPLAY PANEL

    packet

  • INGREDIENTS AND APPEARANCE
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!