Label: SUMMERS EVE ACTIVE CHAFE- dimethicone gel

  • NDC Code(s): 0132-8744-42
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 March 8, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

  • Purpose

    Dimethicone 1.2%...................................Skin Protectant

  • Use

          Temporarily protects and helps relieve chafed, chapped, or cracked skin

  • Warnings

    For external use only.

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    do not get into eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms lasts more than 7 days or clear up and occur again within a few days

    Keep out of reach of children.

    If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    Apply as needed.

  • Other information

          Store at 20° – 25°C (68°-77°F)

  • Inactive Ingredients

    dimethicone, dimethicone/vinyl dimethicone crosspolymer, cyclopentasiloxane, vinyl dimethicone/methicone silsesquioxane crosspolymer, silica dimethyl silylate 

  • Questions?

    866 – 787 – 6383 or  Summerseve.com

  • PRINCIPAL DISPLAY PANEL

    Summer’s Eve Active Chafe Gel

    Dimethicone 1.2%/Skin Protectant

    Net Wt. 1.5 oz (42g)

    PRINCIPAL DISPLAY PANEL Summer’s Eve Active Chafe Gel Dimethicone 1.2%/Skin Protectant Net Wt. 1.5 oz (42g)

  • INGREDIENTS AND APPEARANCE
    SUMMERS EVE ACTIVE CHAFE 
    dimethicone gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-8744
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE12 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-8744-421 in 1 CARTON01/12/2021
    142 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34701/12/2021
    Labeler - C.B. Fleet Company, Inc. (003119054)
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