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.
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- Active Ingredients
For external use only · Keep out of reach of childrenClose
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.Close
For external use only · Keep out of the reach of childrenClose
- 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 ingredientsClose
- 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 daysClose
- 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, MethylisothiazolinoneClose
- Other Information
Questions or Comments? Call 305-231-7229 or visit www.HUSHgel.comClose
- INGREDIENTS AND APPEARANCE
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)