Label: NUMBED AS FXXK- topical anesthetic cream cream
- NDC Code(s): 83371-112-11
- Packager: Blackbull Store LLC
- 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 July 9, 2023
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- Active Ingredient(s)
- Purpose
- Use
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- STOP USE
- Directions
- Other information
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Inactive ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol, Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Ceteth-10 Phosphate, Cyclopentasiloxane, Denatonium Benzoate,Dicetyl Phosphate, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Ethylhexylglycerin, Gyceryl Stearate, lsohexadecane, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Maltodextrin, Phenoxyethanol, Simmondsia Chinensis(Jojoba) Seed Oil, Steareth-21, Tocopheryl Acetate, Water.
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INGREDIENTS AND APPEARANCE
NUMBED AS FXXK
topical anesthetic cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83371-112 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 mg in 100 mL Inactive Ingredients Ingredient Name Strength STEARETH-21 (UNII: 53J3F32P58) ISOHEXADECANE (UNII: 918X1OUF1E) ALCOHOL 95% (UNII: 7528N5H79B) PHENOXYETHANOL (UNII: HIE492ZZ3T) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O) JOJOBA OIL (UNII: 724GKU717M) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ALOE VERA LEAF (UNII: ZY81Z83H0X) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) MALTODEXTRIN (UNII: 7CVR7L4A2D) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83371-112-11 57 mL in 1 TUBE; Type 0: Not a Combination Product 08/10/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/10/2023 Labeler - Blackbull Store LLC (085247371)