Label: ACTS38 BOSWELLIAGEL (100ML)- boswellia serrata extract,, acetyl glucosamine , centella asiatica extract, sodium hyaluronate gel

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 22, 2022

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

  • ACTIVE INGREDIENT

    - Boswellia Serrata Extract
    - Acetyl Glucosamine
    - Centella Asiatica Extract
    - Sodium Hyaluronate

  • PURPOSE

    Simply massage the ACT38 over painful areas for beneficial effects including:
    - Pain relief for Arthritic Pain, Neck and Shoulder Pain, Back Pain and more
    - Decrease in joint swelling
    - Improved blood supply to inflamed joints
    - Increasing joint suppleness
    - Powerful anti-inflammatory effects
    - Relieves stiff and sore muscles

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • INDICATIONS & USAGE

    Take an appropriate amount of the product and gently rub it on necessary areas such as knees,
    elbows, ankles, and wrists to spread it evenly.

  • WARNINGS

    1) If there are abnormal symptoms or side effects such as red spots, swelling, or itching in the
    area of use of cosmetics or direct sunlight after use, consult a specialist
    2) refrain from using injured areas
    3) Precautions for storage and handling
    A) Keep out of reach of children
    B) Store away from direct sunlight

  • DOSAGE & ADMINISTRATION

    for external use only

  • INACTIVE INGREDIENT

    Water
    Butylene Glycol
    Glycerin
    Alcohol
    Methyl Gluceth-20
    1,2-Hexanediol
    Boswellia Serrata Extract(12,000ppm)
    Carbomer
    Tromethamine
    Cellulose Gum
    Bis-Peg-18 Methyl Ether Dimethyl Silane
    Ammonium Acryloyldimethyltaurate/Vp
    Copolymer
    Portulaca Oleracea Extract
    Opuntia Coccinellifera
    Taraxacum Officinale
    Sesamum Indicum(Sesame) Seed Extract
    Methyl Diisopropyl Propionamide
    Betaine
    Camphor
    Peg-60 Hydrogenated Castor Oil
    Glycyrrhiza Glabra (Licorice) Root Extract
    Platycodon Grandiflorum Root Extract
    Poria Cocos Extract
    Sodium Pca
    Acetyl Glucosamine
    Coix Lacryma-Jobi Ma-Yuen Seed Extract
    Paeonia Albiflora Root Extract
    Angelica Gigas Extract
    Polygonatum Odoratum Extract
    Artemisia Vulgaris Extract
    Cornus Officinalis Fruit Extract
    Rehmannia Glutinosa Root Extract
    Scutellaria Baicalensis Root Extract
    Astragalus Membranaceus Root Extract
    Sorbitol
    Allantoin
    Serine
    Disodium Edta
    Centella Asiatica Extract
    Sodium Hyaluronate
    Glycine
    Glutamic Acid
    Lysine
    Alanine
    Arginine
    Threonine
    Ethylhexylglycerine
    Prolin

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ACTS38 BOSWELLIAGEL (100ML) 
    boswellia serrata extract,, acetyl glucosamine , centella asiatica extract, sodium hyaluronate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82967-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    N-ACETYLGLUCOSAMINE (UNII: V956696549) (N-ACETYLGLUCOSAMINE - UNII:V956696549) N-ACETYLGLUCOSAMINE0.1 g  in 100 mL
    HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONATE SODIUM0.01 g  in 100 mL
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) (INDIAN FRANKINCENSE - UNII:4PW41QCO2M) INDIAN FRANKINCENSE1.2 g  in 100 mL
    CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U) CENTELLA ASIATICA0.01 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82967-0002-1100 mL in 1 TUBE; Type 0: Not a Combination Product10/23/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/23/2022
    Labeler - A-Lot Biologics Inc (695416663)
    Registrant - A-Lot Biologics Inc (695416663)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-Lot Biologics Inc695416663manufacture(82967-0002)