Label: RESTORIDEN LIDOCAINE CREAM- lidocaine cream
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Contains inactivated NDC Code(s)
NDC Code(s): 76348-583-01, 76348-583-02 - Packager: RENU LABORATORIES, INC.
- 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 October 20, 2020
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- STATEMENT OF IDENTITY
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- QUESTIONS
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INACTIVE INGREDIENT
Arnica Montana Extract, Capryl Glycol, Caprylic/Capric Triglycerides, Cetearyl Alcohol, Deionized Water, Emulsifying Wax NF, Ethylhexylglycerin, Glycerin,Hexylene Glycol, Hippophae Rhamnoides Fruit and Seed Oils, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Stearic Acid, Tetrasodium EDTA, Tocopherol
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RESTORIDEN LIDOCAINE CREAM
lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-583 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 2.24 g in 56 g Inactive Ingredients Ingredient Name Strength HEXYLENE GLYCOL (UNII: KEH0A3F75J) HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) STEARIC ACID (UNII: 4ELV7Z65AP) TOCOPHEROL (UNII: R0ZB2556P8) POLYSORBATE 20 (UNII: 7T1F30V5YH) HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J) GLYCERIN (UNII: PDC6A3C0OX) SODIUM HYDROXIDE (UNII: 55X04QC32I) EDETATE SODIUM (UNII: MP1J8420LU) WHITE WAX (UNII: 7G1J5DA97F) JOJOBA OIL (UNII: 724GKU717M) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-583-01 1 in 1 BOX 10/20/2020 1 NDC:76348-583-02 56 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/20/2020 Labeler - RENU LABORATORIES, INC. (945739449) Establishment Name Address ID/FEI Business Operations RENU LABORATORIES, INC. 945739449 manufacture(76348-583)