Dermarad Relief Topical Rehydrating Emulsion

Dermarad Relief Topical Rehydrating Emulsion
SPL v7
SPL
SPL Set ID d5e11f73-918b-eeac-e053-2995a90a4a83
Route
TOPICAL
Published
Effective Date 2023-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (1.18 g) Lidocaine (4.72 g)
Inactive Ingredients
Alpha-tocopherol Dihydroeugenol Phenoxyethanol Caprylyl Glycol Ethylhexylglycerin Cetyl Alcohol Ppg-51/smdi Copolymer Hexylene Glycol Niacinamide Propylene Glycol Stearic Acid Jojoba Oil White Petrolatum Cetostearyl Alcohol Dimethicone Polyoxyl 20 Cetostearyl Ether Dimethyl Isosorbide Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.s) Glyceryl Stearate/peg-100 Stearate Glycol Stearate Isoeugenyl Acetate Peg-100 Stearate Water Medium-chain Triglycerides Sodium Pyrrolidone Carboxylate Glycerin Edetic Acid Sodium Hydroxide Squalane Hydroxypropyl Corn Starch (5% Substitution By Weight)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-03

Description

Active Ingredients Allantoin 1% Lidocaine 4%


Medication Information

Warnings and Precautions

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.

Indications and 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.

Dosage and 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.

Description

Active Ingredients Allantoin 1% Lidocaine 4%

Section 50565-1

Keep out of reach of children

Section 50570-1

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.

Section 51727-6

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.

Section 53413-1

DermaMedics LLC, Oklahoma City, OK 73104

www.dermamedics.com

1-800-990-6552

Section 55105-1

Purpose

Skin Protectant

Topical Analgesic

Section 55106-9

Active Ingredients

Allantoin 1%

Lidocaine 4%

Section 69718-5

DermaRad Relief

Topical Rehydrating Emulsion

Dermarad Relief Product Label

DERMARAD LABEL AND OUTER BOX


Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

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.

Section 53413-1 (53413-1)

DermaMedics LLC, Oklahoma City, OK 73104

www.dermamedics.com

1-800-990-6552

Section 55105-1 (55105-1)

Purpose

Skin Protectant

Topical Analgesic

Section 55106-9 (55106-9)

Active Ingredients

Allantoin 1%

Lidocaine 4%

Section 69718-5 (69718-5)

DermaRad Relief

Topical Rehydrating Emulsion

Dermarad Relief Product Label (DermaRad Relief Product Label)

DERMARAD LABEL AND OUTER BOX


Advanced Ingredient Data


Raw Label Data

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