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.

Active Ingredient

Active Ingredients

Allantoin 1%

Lidocaine 4%

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 69718-5

DermaRad Relief

Topical Rehydrating Emulsion

Dermarad Relief Product Label

DERMARAD LABEL AND OUTER BOX


Structured Label Content

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.

Active Ingredient (55106-9)

Active Ingredients

Allantoin 1%

Lidocaine 4%

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.

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 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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