Label: LOVETTA TATTOO HEALING SKIN PROTECTANT- colloidal oatmeal gel

  • Category: HUMAN OTC DRUG LABEL

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 16, 2022

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  • Active ingredient

    Colloidal oatmeal 2%

  • Purpose

    Skin protectant

  • Uses

    ■ Temporarily protects and helps relieve minor skin irritation and itching due to newly tattooed skin .

    ■ Helps to moisturize skin and relieve dryness .

    ■ Helps to protect newly tattooed skin .

  • Warnings

    For external use only

  • When using this product

    • do not get into eyes
  • Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again withing a few days
  • Keep out of reach of children.

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

  • Directions

    ■ Gently clean around affected area. ■ Apply a moderate amount of gel directly onto the affected area.

    ■ Apply as needed.

  • Inactive ingredients

    Aloe Vera, Carbomer , Centella asiatica (gotu kola) extract , Echinacea purpurea (purple coneflower) extract , Equisetum arvense (field horsetail) extract, Eucalyptus globulus (eucalyptus) extract , Fucus vesiculosus (seaweed) extract, Hedera helix (Ivy) extract , Lactamide MEA, Mel ia azadirachta (neem) extract , Mimosa tenuiflora (tepezcohuite) bark extract , Panthenol (vitamin 812), PEG/PPG- 25/25 Dimethicone, Phenoxyethanol , Polyquaternium , Prunus amygdalus dulcis (almond) extract, Rosmarinus officinalis (rosemary) extract , Triethanolamine, Water (aqua) .

  • Other information

    ■ Store at 59 to 86 °F (15 to 30 °C).

    ■ Tamper Evident : DO NOT USE IF SAFETY SEAL ON TUBE IS BROKEN OR MISSING.

  • Questions

    305-505-1116 or www.lovettatc.com

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    LOVETTA TATTOO HEALING SKIN PROTECTANT 
    colloidal oatmeal gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82596-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ROSMARINUS OFFICINALIS FLOWERING TOP (UNII: 8JM482TI79)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    POLIDRONIUM CHLORIDE (UNII: 6716Z5YR3G)  
    ALMOND (UNII: 3Z252A2K9G)  
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    ECHINACEA PURPUREA (UNII: QI7G114Y98)  
    EQUISETUM ARVENSE TOP (UNII: 1DP6Y6B65Z)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
    HEDERA HELIX FLOWERING TWIG (UNII: 3D10KUA6BM)  
    N-LACTOYL ETHANOLAMINE (UNII: 900T44YNC7)  
    AZADIRACHTA INDICA WHOLE (UNII: MRL4DVG1F6)  
    MIMOSA TENUIFLORA BARK (UNII: 515MQE449I)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PEG/PPG-25/25 DIMETHICONE (UNII: ND6MYD0T84)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82596-200-10100 g in 1 TUBE; Type 0: Not a Combination Product11/16/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01611/16/2022
    Labeler - LOVETTA COSMETICS LLC (045229605)
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