Label: ALOE VERA GEL gel

  • 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 November 3, 2020

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  • ACTIVE INGREDIENT

    Active ingredients--------------purpose

    Glycerine..........10%

    Propylene Glycol..........4%

  • PURPOSE

    Uses:
    Keep skin moist. Recommended for repeated use.

  • WARNINGS

    Warnings:

    Keep away from fire or flame.For external use only.Keep out of reach of children.Keep out of reach of eyes.

  • INDICATIONS & USAGE

    Directions:

    Apply small amount in your palm and smear on the skin.

  • DOSAGE & ADMINISTRATION

    Other Information

    Do not store above 110F(43C) May discolor certain fabric or surfaces. Harmful to wood finishes and plastics.


  • KEEP OUT OF REACH OF CHILDREN

    Children under 6 years of age should be super vised when using this product.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water,Carbomer,Aloe barbadensis leaf juice power,Edetic acid,Ethoxylated hydrogenated castor oil,Fragrance,Dimethyloldimethy hydantoin,Triethanolamine.

  • PRINCIPAL DISPLAY PANEL

    image of Aloe Vera Gel

  • INGREDIENTS AND APPEARANCE
    ALOE VERA GEL 
    aloe vera gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-220
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN10 g  in 100 g
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 82 g  in 100 g
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.8 g  in 100 g
    ALOE (UNII: V5VD430YW9) 0.2 g  in 100 g
    EDETIC ACID (UNII: 9G34HU7RV0) 0.1 g  in 100 g
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) 1 g  in 100 g
    AROMADENDRIN (UNII: 7YA4640575) 0.5 g  in 100 g
    DMDM HYDANTOIN (UNII: BYR0546TOW) 0.5 g  in 100 g
    TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W) 0.9 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47993-220-0110 g in 1 TUBE; Type 0: Not a Combination Product07/23/2015
    2NDC:47993-220-0215 g in 1 TUBE; Type 0: Not a Combination Product07/23/2015
    3NDC:47993-220-0320 g in 1 TUBE; Type 0: Not a Combination Product07/23/2015
    4NDC:47993-220-0430 g in 1 TUBE; Type 0: Not a Combination Product07/23/2015
    5NDC:47993-220-0550 g in 1 TUBE; Type 0: Not a Combination Product07/23/2015
    6NDC:47993-220-0660 g in 1 TUBE; Type 0: Not a Combination Product07/23/2015
    7NDC:47993-220-07100 g in 1 TUBE; Type 0: Not a Combination Product07/23/2020
    8NDC:47993-220-08237 g in 1 TUBE; Type 0: Not a Combination Product07/23/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35602/20/2015
    Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
    Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
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