Label: LIDOCREAM PLUS- lidocaine hydrochloride cream
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Contains inactivated NDC Code(s)
NDC Code(s): 86089-200-01 - Packager: AEC Consumer Products, 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 February 28, 2022
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Use
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Warnings
For external use only
Do not use: • in large quantities, particularly over raw or blistered surfaces • for more than one week without consulting a doctor
When using this product: • use only as directed • avoid contact with the eyes • do not bandage or apply local heat (such as heating pads) to the area of use
Stop use and ask a doctor if: • condition worsens • symptoms persist more than 7 days • symptoms clear up and occur again within a few days
If pregnant or breast-feeding, ask a health professional before use.
- Directions
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Inactive Ingredients
Allantoin, Arnica Montana Flower, Astaxanthin, Benzyl Alcohol, Bergamot Oil, Butylated Hydroxytoluene, C13-14 Isoparaffin, Carbomer, Cetostearyl Alcohol, Cyclomethicone, Diethylene Glycol Monoethyl Ether, Dimethicone, Dimethiconol, Dimethyl Sulfone, Edetate Sodium, Emu Oil, Glycerin, Glyceryl Stearate Se, Indian Frankincense, Isopropyl Palmitate, Laureth-7, Levomenol, N-Acetyl-Glucosamine Thiazoline, Peg-100 Stearate, Phenoxyethanol, Polyacrylamide, Polyquaternium-10, Potassium Sorbate, Propylene Glycol, Salicylic Acid, Sodium Hydroxide, Stearic Acid, Tea Tree Oil, Tocopherol, Trolamine, Turmeric Oil, Vaccinium Myrtillus Anthocyanosides, Vitamin A Palmitate, Water
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INGREDIENTS AND APPEARANCE
LIDOCREAM PLUS
lidocaine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:86089-200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 4 g in 100 g Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) ASTAXANTHIN (UNII: 8XPW32PR7I) BENZYL ALCOHOL (UNII: LKG8494WBH) BERGAMOT OIL (UNII: 39W1PKE3JI) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CYCLOMETHICONE (UNII: NMQ347994Z) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHICONE 200 (UNII: RGS4T2AS00) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) EDETATE SODIUM (UNII: MP1J8420LU) EMU OIL (UNII: 344821WD61) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) LAURETH-7 (UNII: Z95S6G8201) LEVOMENOL (UNII: 24WE03BX2T) N-ACETYL-GLUCOSAMINE THIAZOLINE (UNII: ML5FHL557A) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) POLYQUATERNIUM-10 (400 MPA.S AT 2%) (UNII: HB1401PQFS) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SALICYLIC ACID (UNII: O414PZ4LPZ) SODIUM HYDROXIDE (UNII: 55X04QC32I) STEARIC ACID (UNII: 4ELV7Z65AP) TEA TREE OIL (UNII: VIF565UC2G) TOCOPHEROL (UNII: R0ZB2556P8) TROLAMINE (UNII: 9O3K93S3TK) TURMERIC OIL (UNII: 6KGS8SP16U) VACCINIUM MYRTILLUS ANTHOCYANOSIDES (UNII: R911H793SU) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86089-200-01 96.4 g in 1 TUBE; Type 0: Not a Combination Product 03/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/01/2022 Labeler - AEC Consumer Products, LLC (080994102) Establishment Name Address ID/FEI Business Operations AEC Consumer Products, LLC 080994102 pack(86089-200)
