Label: OHEAL TATTOO NUMBING CREAM- tattoo numbing cream cream
- NDC Code(s): 83176-012-01
- Packager: Dr.luke Healthcare LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 June 30, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warnings
- Do not use
- When Using
- Stop Use
- Ask Doctor
- Keep Oot Of Reach Of Children
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Directions
Perform a patch test on the back of your hand before using it to check for skin sensitivity.When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
Apply up to 2 times a day.(Children under 12 years of age: consult a doctor.) - Other information
- Inactive ingredients
- Questions
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OHEAL TATTOO NUMBING CREAM
tattoo numbing cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83176-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 mL Inactive Ingredients Ingredient Name Strength SHEA BUTTER (UNII: K49155WL9Y) SQUALANE (UNII: GW89575KF9) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERYL 1-STEARATE (UNII: 258491E1RZ) TETRACAINE (UNII: 0619F35CGV) PROCAINE (UNII: 4Z8Y51M438) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) BORNEOL (UNII: M89NIB437X) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) MENTHA ARVENSIS LEAF (UNII: A4IWO4DDZ9) CENTELLA ASIATICA ROOT (UNII: 8MXU1P42J0) PRILOCAINE (UNII: 046O35D44R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) XANTHAN GUM (UNII: TTV12P4NEE) TOCOPHEROL (UNII: R0ZB2556P8) RICE GERM (UNII: 7N2B70SFEZ) JOJOBA OIL (UNII: 724GKU717M) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL (UNII: L7T10EIP3A) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83176-012-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/29/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M016 06/29/2023 Labeler - Dr.luke Healthcare LLC (118868014) Establishment Name Address ID/FEI Business Operations Dr.luke Healthcare LLC 118868014 label(83176-012) , manufacture(83176-012)