Label: BLACK FLY GUARD- neem oil

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated December 17, 2021

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  • ACTIVE INGREDIENT

    NEEM OIL 3%

  • PURPOSE

    BLACK FLY GUARD

  • USES

    • PREVENTS BLACK FLY BITES
    • ALL NATURAL PLANT OILS
    • LONG LASTING PROTECTION
  • WARNINGS

    TOPICAL OIL - FOR EXTERNAL USE ONLY - KEEP OUT OF EYES. FLUSH THOROUGHLY AND GENTLY WITH WARM WATER FOR 10-15 MINUTES. STOP USE AND CONSULT PHYSICIAN IF RASH OR IRRITATION DEVELOPS.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN: IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • DIRECTIONS

    (FOR CHILDREN 2 YEARS AND OLDER AND ADULTS):

    APPLY SUNSCREEN FIRST, ESPECIALLY SPRAY-ON SUNSCREENS WHICH CONTAIN ALCOHOL (ALCOHOL REMOVES OUR PRODUCT). IF A SPRAY-ON SUNSCREEN IS REAPPLIED, THEN OUR PRODUCT MUST BE REAPPLIED TOO.

  • OTHER INGREDIENTS

    FRACTIONATED COCONUT OIL, OLIVE OIL, AVOCADO OIL, HIGH OLEIC SAFFLOWER OIL, CINNAMOM OIL, D-ALPHA TOCOPHEROL (VITAMIN E).

  • PRINCIPAL DISPLAY PANEL

    01b LBL_105172.Black_Fly_guard_label

  • INGREDIENTS AND APPEARANCE
    BLACK FLY GUARD 
    neem oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63264-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T) (AZADIRACHTA INDICA SEED OIL - UNII:4DKJ9B3K2T) AZADIRACHTA INDICA SEED OIL3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63264-201-14118 mL in 1 BOTTLE; Type 0: Not a Combination Product12/17/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/17/2021
    Labeler - RESOLUTIONS LLC (047149101)
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