Label: PRANAROM GOOD SAMARITAN ALCOHOL ANTISEPTIC- alcohol liquid

  • 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 September 8, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Helps reduce bacteria on skin. Recommended for repeated use.

  • Warnings

    For external use only.

    Other information

    • Flammable. Keep away from fire, sparks, and sources of ignition.
    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)

    When using this product Keep out of eyes. In case of contact with eyes, fush thoroughly with water. Avoid contact with broken skin.

    Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    Place enough product on hands to cover all surfaces. Rub hands together until dry. For children under 6, use adult
    supervision. Not recommended for infants.

  • Inactive ingredients

    Water, Glycerin,* Ricinus communis (Castor) Oil,* Cinnamomum verum (Cinnamon) Leaf Oil,* Citrus limon (Lemon) Peel Oil,* Rosmarinus officinalis (Rosemary) Leaf Oil,* Eucalyptus radiata Leaf Oil,* Eugenia caryophyllus (Clove) Bud Oil,* Cinnamomum zeylanicum (Cinnamon) Bark Oil.*

  • Package Label - Principal Display Panel

    PRANARÕM

    HAND SANITIZER

    Moisturizing Formula

    Non-Sterile Solution

    GOOD SAMARITAN

    Alcohol antiseptic 70% topical solution

    Net wt xx fl. oz | xx ml

    *CERTIFIED ORGANIC

    pranarom.us

    Minneapolis, MN 55427

    Certified Organic

    by ECOCERT ICO.

    Product Label_30mL

  • INGREDIENTS AND APPEARANCE
    PRANAROM GOOD SAMARITAN ALCOHOL ANTISEPTIC 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78596-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CLOVE OIL (UNII: 578389D6D0)  
    EUCALYPTUS RADIATA LEAF OIL (UNII: SB9A7612BD)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    CINNAMON LEAF OIL (UNII: S92U8SQ71V)  
    LEMON OIL (UNII: I9GRO824LL)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78596-002-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product09/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/08/2020
    Labeler - Veriditas Botanicals LLC (174766845)
    Registrant - Veriditas Botanicals LLC (174766845)
    Establishment
    NameAddressID/FEIBusiness Operations
    Veriditas Botanicals LLC174766845manufacture(78596-002) , analysis(78596-002) , label(78596-002) , pack(78596-002) , relabel(78596-002) , repack(78596-002)
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