Label: HUSH ANESTHETIC- lidocaine gel

  • NDC Code(s): 49947-002-02, 49947-002-04
  • Packager: HUSH Anesthetic
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/10

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

  • Active Ingredients

    Lidocaine

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  • Purpose

    Topical Anesthetic

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  • Warnings

    For external use only · Keep out of reach of children

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  • Uses

    Before skin is broken apply a thick layer of HUSH Gel in the area to be Tattooed. Spread evenly throughout. Reapply along the edges. Wrap the area with a plastic wrap and allow 1 hour for absorption. Remove the plastic wrap and prep skin for procedure.

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  • Warnings

    For external use only · Keep out of the reach of children

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  • Before skin is broken apply a thick layer of HUSH Gel in the area to be Tattooed. Spread evenly throughout. Reapply along the edges. Wrap the area with a plastic wrap and allow 1 hour for absorption. Remove the plastic wrap and prep skin for procedure.
  • Do Not Use

    In Blistered Areas · In the eyes · If allergic to ingredients

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  • Stop Use and ask a doctor if

    · skin becomes irritated · condition worsens or symptoms last more than 7 days · symptoms clear up and reoccur within a few days

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  • Inactive ingredients

    Water, SD Alchohol 40B, Aloe Barbadensis Leaf Extract, Propylene Glycol, Triethanolamine, Glycerin, Menthol, Chamomile (Chamomilla Recutita) Flower Extract, Calendula Officinalis Flower Extract, Green Tea (Camellia Sinensis) Leaf Extract, Comfrey (Symphytum Officinale) Root Extract, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Caprylyl Glycol, Methylisothiazolinone

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  • Other Information

    Questions or Comments? Call 305-231-7229 or visit www.HUSHgel.com

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  • INGREDIENTS AND APPEARANCE
    HUSH ANESTHETIC 
    lidocaine gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49947-002
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE (LIDOCAINE) LIDOCAINE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ALCOHOL  
    ALOE VERA LEAF  
    PROPYLENE GLYCOL  
    TROLAMINE  
    GLYCERIN  
    MENTHOL  
    CHAMAEMELUM NOBILE FLOWER  
    CALENDULA OFFICINALIS FLOWER  
    GREEN TEA LEAF  
    COMFREY ROOT  
    CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)  
    EDETATE DISODIUM ANHYDROUS  
    CAPRYLYL GLYCOL  
    METHYLISOTHIAZOLINONE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49947-002-04 113.4 g in 1 BOTTLE
    2 NDC:49947-002-02 56.7 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 12/01/2012
    Labeler - HUSH Anesthetic (012011309)
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