DERMARAD RELIEF- lidocaine emulsion emulsion

DermaRad Relief by

Drug Labeling and Warnings

DermaRad Relief by is a Otc medication manufactured, distributed, or labeled by RENU LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Allantoin 1%

Lidocaine 4%

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.

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

Purpose

Skin Protectant

Topical Analgesic

QUESTIONS

DermaMedics LLC, Oklahoma City, OK 73104

www.dermamedics.com

1-800-990-6552

DOSAGE & ADMINISTRATION

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.

INDICATIONS & USAGE

Uses

• For the temporary relief of pain and itching associated with minor burns, sunburn, or minor skin irritations.
• Temporarily protects minor burns.
• Temporarily protects and helps relieve chapped or cracked skin.
  

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

DermaRad Relief

Topical Rehydrating Emulsion

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMARAD RELIEF 
lidocaine emulsion emulsion

Product 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)