DERMARAD RELIEF- lidocaine emulsion emulsion 
RENU LABORATORIES, INC.

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.

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DermaRad Relief Topical Rehydrating Emulsion

Active Ingredients

Allantoin 1%

Lidocaine 4%

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:

Do not use in large quantities, particularly over raw surfaces or blistered areas.

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

Skin Protectant

Topical Analgesic

DermaMedics LLC, Oklahoma City, OK 73104

www.dermamedics.com

1-800-990-6552

Directions: Adults and children 2 years of age and older,

apply to affected areas no more than 3 to 4 times daily.

For children under 2 years of age, consult your physician.

Uses

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.

DermaRad Relief

Topical Rehydrating Emulsion

Keep out of reach of children

118 ml product labelSealEndBox_01.06.2023

DERMARAD RELIEF 
lidocaine emulsion emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-720
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN1.18 g  in 118 mL
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4.72 g  in 118 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76348-720-011 in 1 BOX01/03/2022
1NDC:76348-720-04118 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/03/2022
Labeler - RENU LABORATORIES, INC. (945739449)
Establishment
NameAddressID/FEIBusiness Operations
RENU LABORATORIES, INC.945739449manufacture(76348-720)

Revised: 1/2023
Document Id: e4e298ee-f3d5-dea7-e053-2a95a90a0560
Set id: d5e11f73-918b-eeac-e053-2995a90a4a83
Version: 6
Effective Time: 20230106
 
RENU LABORATORIES, INC.