Llorens-dermagesic Liquid 120

Llorens-dermagesic Liquid 120
SPL v5
SPL
SPL Set ID 8b3f8894-1ed7-4888-a42c-8510d6161edd
Route
TOPICAL
Published
Effective Date 2020-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (1 mg) Zinc Cation (0.4 mg) Ferric Oxide Red
Inactive Ingredients
Glycerin Glyceryl Stearate Se Peg-100 Stearate Cetostearyl Alcohol Methylparaben Propylparaben Aloe Vera Leaf Avena Sativa Whole Hypromellose 2208 (100 Mpa.s) Menthol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-01-01

Description

Active Ingredients                   Purpose Pramozine HCl .... 1% ............ Anesthetic/Analgesic Zinc Oxide .........0.4% ............ Skin Protectant Calamine ...........0.4% ............ Skin Protectant


Medication Information

Warnings and Precautions

Warnings

  • For external use only. Avoid contact with the eyes
  • Not for Pediatric use
  • Hypersensitivity to "caine" anesthetics

Indications and Usage

Uses

  • for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor irritations
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac.
Dosage and Administration

Directions  SHAKE WELL

  • Adults and children 2 years of age and older apply to affected area not more than 3 to 4 times daily
  • Children under 2 years of age ask a doctor
  • Do not use more often than directed
Description

Active Ingredients                   Purpose Pramozine HCl .... 1% ............ Anesthetic/Analgesic Zinc Oxide .........0.4% ............ Skin Protectant Calamine ...........0.4% ............ Skin Protectant

Section 50565-1

KEEP OUT OF REACH OF CHILDRENIf swallowed, get medical help or contact a Poison Control Center right away.

Section 50570-1

Do not use

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use

  • on chicken pox
  • on measles

Stop use and ask a doctor ifcondition worsens or does not improve within 7 days

  • symptoms persist for more than 7 days or clear up and occur again within a few days

Section 51727-6

Inactive Ingredients: Glycerin, glyceryl stearate, PEG-100 Stearate, cetearyl alcohol, methylparaben, propylparaben, aloe barbadensis leaf juic (aloe vera), avena sativa (oat) kernel colloidal oatmeal, fregrance, hydroxypropyl methylcellulose, menthol, purified water

Section 51945-4

Section 53413-1

Questions:  1-866-595-5598

Section 55105-1

Purpose

Anesthetic/Analgesic

Skin Protectant

Section 55106-9

Active Ingredients                   Purpose

Pramozine HCl .... 1% ............ Anesthetic/Analgesic

Zinc Oxide .........0.4% ............ Skin Protectant

Calamine ...........0.4% ............ Skin Protectant


Structured Label Content

Indications and Usage (34067-9)

Uses

  • for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor irritations
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac.
Dosage and Administration (34068-7)

Directions  SHAKE WELL

  • Adults and children 2 years of age and older apply to affected area not more than 3 to 4 times daily
  • Children under 2 years of age ask a doctor
  • Do not use more often than directed
Warnings and Precautions (34071-1)

Warnings

  • For external use only. Avoid contact with the eyes
  • Not for Pediatric use
  • Hypersensitivity to "caine" anesthetics

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDRENIf swallowed, get medical help or contact a Poison Control Center right away.

Section 50570-1 (50570-1)

Do not use

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use

  • on chicken pox
  • on measles

Stop use and ask a doctor ifcondition worsens or does not improve within 7 days

  • symptoms persist for more than 7 days or clear up and occur again within a few days

Section 51727-6 (51727-6)

Inactive Ingredients: Glycerin, glyceryl stearate, PEG-100 Stearate, cetearyl alcohol, methylparaben, propylparaben, aloe barbadensis leaf juic (aloe vera), avena sativa (oat) kernel colloidal oatmeal, fregrance, hydroxypropyl methylcellulose, menthol, purified water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions:  1-866-595-5598

Section 55105-1 (55105-1)

Purpose

Anesthetic/Analgesic

Skin Protectant

Section 55106-9 (55106-9)

Active Ingredients                   Purpose

Pramozine HCl .... 1% ............ Anesthetic/Analgesic

Zinc Oxide .........0.4% ............ Skin Protectant

Calamine ...........0.4% ............ Skin Protectant


Advanced Ingredient Data


Raw Label Data

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