Dermarad Relief Post Radiation Calming Serum With 3% Lidocaine

Dermarad Relief Post Radiation Calming Serum With 3% Lidocaine
SPL v2
SPL
SPL Set ID e5d64929-fb9c-7ebc-e053-2995a90a9318
Route
TOPICAL
Published
Effective Date 2022-08-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (1.5 g)
Inactive Ingredients
Cyclomethicone 5 Petrolatum Jojoba Oil Dimethicone Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Isoeugenyl Acetate Squalane Dihydroeugenol Sunflower Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-08

Description

Active Ingredient Lidocaine 3%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

Temporarily relieves pain and itching due to

  • sunburn
  • minor burns
  • minor cuts
  • minor skin irritations
Dosage and Administration

Directions

  • adults and children 2 years and older apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age : ask a doctor
Description

Active Ingredient Lidocaine 3%

Section 43683-2

No changes at all to section. We have cloned submission for a second product with another NDC Code.

No changes to any section except Principal Package display and NDC #

Section 50565-1

Keep out of reach of children

If swallowed - get medical help or contact a poison control center right away

Section 50566-9

Stop use and ask a doctor if

  • Condition gets worse
  • Symptoms persist for more than 7 days
  • Symptoms clear up and occur again in a few days
Section 50567-7

When using this product

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

Avoid contact with the eyes

Section 51727-6

Inactive Ingredients:

Cyclopentasiloxane, Dihydroeugenol, Dimethicone, Dimethiconol, Dimethicone/Vinyl Dimethicone Crosspolymer, Helianthus Annuus (Sunflower) Seed Oil, Isoeugenyl Acetate, Petrolatum, Simmondsia Chinensis (Jojoba) Seed Oil, Squalane.

Section 51945-4

PRODUCT BOX FOR POST RADIATION CALMING SERUM

PRODUCT ARTWORK

Section 55105-1

Purpose

External Analgesic

Section 55106-9

Active Ingredient

Lidocaine 3%

Section 60561-8

Manufactured in the U.S.A. for Dermamedics, LLC

Oklahoma City, OK 73112

www.dermamedics.com

1 800 990 6552

Section 69718-5

DERMAMEDICS

Post Radiation

Calming

Serum with

3 % Lidocaine


Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves pain and itching due to

  • sunburn
  • minor burns
  • minor cuts
  • minor skin irritations
Dosage and Administration (34068-7)

Directions

  • adults and children 2 years and older apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age : ask a doctor
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 43683-2 (43683-2)

No changes at all to section. We have cloned submission for a second product with another NDC Code.

No changes to any section except Principal Package display and NDC #

Section 50565-1 (50565-1)

Keep out of reach of children

If swallowed - get medical help or contact a poison control center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • Condition gets worse
  • Symptoms persist for more than 7 days
  • Symptoms clear up and occur again in a few days
Section 50567-7 (50567-7)

When using this product

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

Avoid contact with the eyes

Section 51727-6 (51727-6)

Inactive Ingredients:

Cyclopentasiloxane, Dihydroeugenol, Dimethicone, Dimethiconol, Dimethicone/Vinyl Dimethicone Crosspolymer, Helianthus Annuus (Sunflower) Seed Oil, Isoeugenyl Acetate, Petrolatum, Simmondsia Chinensis (Jojoba) Seed Oil, Squalane.

Section 51945-4 (51945-4)

PRODUCT BOX FOR POST RADIATION CALMING SERUM

PRODUCT ARTWORK

Section 55105-1 (55105-1)

Purpose

External Analgesic

Section 55106-9 (55106-9)

Active Ingredient

Lidocaine 3%

Section 60561-8 (60561-8)

Manufactured in the U.S.A. for Dermamedics, LLC

Oklahoma City, OK 73112

www.dermamedics.com

1 800 990 6552

Section 69718-5 (69718-5)

DERMAMEDICS

Post Radiation

Calming

Serum with

3 % Lidocaine


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)