Label: 70% ISOPROPYL ALCOHOL PE 1L- 70% isopropyl alcohol primal elements 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 October 18, 2020

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

  • Active Ingredients

    Isopropyl Alcohol 70.00% v/v First Aid Antiseptic

  • Uses:

    Helps prevent the risk of infection due to minor cuts, scraps and burns.

  • Warnings:

    For External Use Only

  • Flammable-

    Keep away from fire, flames, heat, sparks,electrical

  • Ask a Doctor before-

    Use for deep or puncture wounds, Animal Bites or serious burns

  • When using this product-

    Do not get into eyes, do not inhale, do not apply over large areas of the body, do not use longer than 1 week

  • Stop and ask a Doctor-

    conditions persist or get worse

  • Keep out of reach of children-

    If swallowed, get medical help or contact a Poison Control Center right away

  • Caution-

    Fumes can be acutely irratating to skin, eyes and respitory system. Do not apply to irritated skin or if excessive irritation develops. Avoid getting into eyes or on mucous membranes. Avoid inhaling this product.

  • Directions-

    Clean affected area- apply a small amount of this product on the area 1 to 3 times a day, may be covered with a sterile bandage, if bandaged, let dry first.

  • Other Information:

    Does not contain nor is intented as a substitute for grain or ethyl alcohol.

  • Inactive Ingredients:

    Water (USP)

  • Uses

    To prevent risk of infection

  • PAckage LAbel

    1 liter 12 pack tray

  • INGREDIENTS AND APPEARANCE
    70% ISOPROPYL ALCOHOL PE 1L 
    70% isopropyl alcohol primal elements liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79071-1001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 30 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79071-1001-21000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/01/2020
    Labeler - Riviera Beverages, LLC (021785705)
    Registrant - Riviera Beverages, LLC (021785705)
    Establishment
    NameAddressID/FEIBusiness Operations
    Riviera Beverages, LLC021785705manufacture(79071-1001)