Label: INFINITE ALOE SKIN CARE- allantoin, colloidal oatmeal lotion

  • 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 May 26, 2017

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

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    ALLANTOIN .5%

    COLLOIDAL OATMEAL .07%

  • PURPOSE

    PURPOSE

    SKIN PROTECTANT

  • INDICATIONS & USAGE

    Uses

    Temporarily protects and helps relieve minor skin irritation and itching due to

    • Eczema
    • Rashes
    • Poison ivy, oak, or sumac
    • Insect bites

    Temporarily protects minor:

    • cuts
    • scrapes
    • burns
    • Helps prevent and temporarily protects and helps relieve chafed,chapped or cracked skin.
    • Helps prevent and protect from the drying effects of wind and cold weather.
  • WARNINGS

    Warnings For external use only. When using this product do not get into eyes. Stop using this product and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or if they clear up and occur again within a few days.
  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    APPLY AS NEEDED

  • INACTIVE INGREDIENT

    Inactive ingredients Aloe Barbadensis leaf juice (Organic Aloe Vera), Deionized water (Aqua), Glycerin (Plant Source), Isopropyl Palmitate, Cetyl Alcohol, Hyaluronic Acid, Glyceryl Stearate, Cetyl Lactate, Soluble Collagen, Dimethyl Sulfone (MSM), Thioctic Acid (Alpha Lipoic Acid), Zea Mays (Organic Corn) Oil, Tocopheryl Acetate (Vitamin E), Ubiquinone (Coenzyme Q10), Retinyl Palmitate (Vitamin A) (and) Cholecalciferol
    (Vitamin D), Hexanoyl Dipeptide-3 Norleucine Acetate (and) Lecithin, Dimethyl MEA (DMAE), Vitis Vinifera (Grape) Seed Oil, Rosa Canina (Rose Hips) Fruit Oil, Prunus Armeniaca (Apricot) Kernel Oil, Yucca Schidigera Extract, Ascorbic Acid (Vitamin C), Thiamine HCL (Vitamin B1 Hydrochloride), Phytonadione (Vitamin K1), Symphytum Officinale (Comfrey) Leaf Extract, Panax Ginseng Root Extract, Foeniculum Vulgare
    (Fennel) Seed Extract, Chamomilla Recutita (Chamomile) Flower Extract, Camellia Oleifera (Green Tea) Leaf Extract, Calendula Officinalis (Marigold) Flower Extract, Citrus Grandis (Grapefruit) Fruit Extract, Usnea Barbata (Lichen) Extract, Niacin (Vitamin B3), Methyl Gluceth 20, Polysorbate 80, DMDM Hydantoin (and) Iodopropynyl Butylcarbamate, Disodium EDTA, BHT, Carbomer, Triethanolamine, Hydrolyzed  Glycosaminoglycans.

  • QUESTIONS

    Questions? Call 1-888-LUV-ALOE (+1 323 906-2880 outside USA) or visit www.InfiniteAloe.com

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    INFINITE ALOE SKIN CARE 
    allantoin, colloidal oatmeal lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69069-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 mL
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.07 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL LACTATE (UNII: A7EVH2RK4O)  
    COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    THIOCTIC ACID, (+)- (UNII: VLL71EBS9Z)  
    CORN OIL (UNII: 8470G57WFM)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    UBIQUINONE Q2 (UNII: I7T5V2W47R)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    HEXANOYL DIPEPTIDE-3 NORLEUCINE ACETATE (UNII: P8A02Z93M6)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    DEANOL (UNII: 2N6K9DRA24)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    YUCCA SCHIDIGERA (UNII: 08A0YG3VIC)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P)  
    PHYTONADIONE (UNII: A034SE7857)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    PANAX GINSENG ROOT WATER (UNII: P9T4K47OM0)  
    FENNEL SEED (UNII: G3QC02NIE6)  
    CHAMOMILE (UNII: FGL3685T2X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GRAPEFRUIT JUICE (UNII: JQ9EK2H6BG)  
    USNEA BARBATA (UNII: D6DVA9TCAP)  
    NIACIN (UNII: 2679MF687A)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CARBOMER 934 (UNII: Z135WT9208)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69069-102-18238 mL in 1 JAR; Type 0: Not a Combination Product05/26/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/26/2017
    Labeler - Economical Solutions, Inc. (DBA INFINITE ALOE) (008046445)