Label: DERMARAD RELIEF- lidocaine emulsion emulsion
- NDC Code(s): 76348-720-01, 76348-720-04
- Packager: RENU LABORATORIES, INC.
- Category: HUMAN OTC DRUG LABEL
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 January 6, 2023
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- ACTIVE INGREDIENT
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WARNINGS
Warnings
For External Use Only
Avoid contact with the eyes.
If condition worsens or if symptoms last more than
7 days or clear up and occur again within a few days,
discontinue use and consult a physician. Do not use on:
- Deep or puncture wounds
- Animal bites
- Serious burns
Do not use in large quantities, particularly over raw surfaces or blistered areas.
- PURPOSE
- QUESTIONS
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
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INACTIVE INGREDIENT
Inactive Ingredients:
Capric/Caprylic Triglyceride, Capryl Glycol, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Deionized Water, Dihydroeugenol,
Dimethicone, Dimethyl Isosorbide, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycol Stearate, Hexylene Glycol, Hydroxypropyl Starch Phosphate, Isoeugenyl Acetate, Niacinamide, PEG-100 Stearate, Petrolatum, Phenoxyethanol, Polyacrylate
Crosspolymer-6, PPG/SMDI Copolymer, Propylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium PCA, Squalane, Stearic Acid, Tocopherol.
- STATEMENT OF IDENTITY
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DERMARAD RELIEF
lidocaine emulsion emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-720 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 1.18 g in 118 mL LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4.72 g in 118 mL Inactive Ingredients Ingredient Name Strength ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) DIHYDROEUGENOL (UNII: A3XE712277) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CETYL ALCOHOL (UNII: 936JST6JCN) PPG-51/SMDI COPOLYMER (UNII: KQ9JG3O3YA) HEXYLENE GLYCOL (UNII: KEH0A3F75J) NIACINAMIDE (UNII: 25X51I8RD4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARIC ACID (UNII: 4ELV7Z65AP) JOJOBA OIL (UNII: 724GKU717M) WHITE PETROLATUM (UNII: B6E5W8RQJ4) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIMETHICONE (UNII: 92RU3N3Y1O) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947) GLYCOL STEARATE (UNII: 0324G66D0E) ISOEUGENYL ACETATE (UNII: 9DF21GI8W6) PEG-100 STEARATE (UNII: YD01N1999R) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) GLYCERIN (UNII: PDC6A3C0OX) EDETIC ACID (UNII: 9G34HU7RV0) SODIUM HYDROXIDE (UNII: 55X04QC32I) SQUALANE (UNII: GW89575KF9) HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) (UNII: 9M44R3409A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-720-01 1 in 1 BOX 01/03/2022 1 NDC:76348-720-04 118 mL in 1 TUBE; 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 01/03/2022 Labeler - RENU LABORATORIES, INC. (945739449) Establishment Name Address ID/FEI Business Operations RENU LABORATORIES, INC. 945739449 manufacture(76348-720)
