dermagesic 202

dermagesic 202
SPL v9
SPL
SPL Set ID bbff6b53-29da-45c1-8ccd-3e9df7f250e0
Route
topical
Published
Effective Date 2020-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
pramoxine (10 mg) zinc cation (4 mg) ferric oxide red
Inactive Ingredients
aloe avena sativa whole cetostearyl alcohol ceteareth-6 ceteareth-25 diazolidinyl urea menthol methylparaben mineral oil propylene glycol propylparaben water stearyl alcohol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2016-04-01

Purpose

Anestheric/Analgesic Skin Protectant

Description

Pramoxine HCl 1% Zinc Oxide 0.4% Calamine 0.4%


Medication Information

Warnings

For external use only. Avoid contact with the eyes

  • Not for Pediatric use
  • Hypersensitivity to "caine" anesthetics

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 if condition 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
Uses
  • for temporary reilef of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor irritation
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac.
Purpose

Anestheric/Analgesic

Skin Protectant

Inactive Ingredients

Aloe Badbadensis Leaf juice (Aloe Vera), Avena Sativa (Oat) Kernal colloidal, cetyl stearyl alcohol, ceteareth-6, ceteareth-25, diazolidinyl urea, fragrance, menthol, methyl paraben, paraffinum liquidum, propylene glycol, propyl paraben, purified water, stearyl alcohol

Description

Pramoxine HCl 1% Zinc Oxide 0.4% Calamine 0.4%

Section 51945-4

Directions 
  • 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
Active Ingredients

Pramoxine HCl 1%

Zinc Oxide 0.4%

Calamine 0.4%

Questions Or Comments

1-866-595-5598

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings

For external use only. Avoid contact with the eyes

  • Not for Pediatric use
  • Hypersensitivity to "caine" anesthetics

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 if condition 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
Uses
  • for temporary reilef of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor irritation
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac.
Purpose

Anestheric/Analgesic

Skin Protectant

Inactive Ingredients

Aloe Badbadensis Leaf juice (Aloe Vera), Avena Sativa (Oat) Kernal colloidal, cetyl stearyl alcohol, ceteareth-6, ceteareth-25, diazolidinyl urea, fragrance, menthol, methyl paraben, paraffinum liquidum, propylene glycol, propyl paraben, purified water, stearyl alcohol

Section 51945-4 (51945-4)

Directions 
  • 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
Active Ingredients

Pramoxine HCl 1%

Zinc Oxide 0.4%

Calamine 0.4%

Questions Or Comments (Questions or Comments)

1-866-595-5598

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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