Drug Listing: Dermasarra

Drug Listing: Dermasarra
SPL v7
SPL
SPL Set ID 1fad8650-8bd6-4711-9121-b9f6ff8bdf6b
Route
TOPICAL
Published
Effective Date 2020-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (0.005 g)
Inactive Ingredients
Carbomer Homopolymer Type C Cetostearyl Alcohol Imidurea Dimethicone Edetate Disodium Glycol Stearate Peg-40 Castor Oil Peg-4 Dilaurate Propylene Glycol Methylparaben Mineral Oil Petrolatum Propylparaben Sodium Cetostearyl Sulfate Stearic Acid Titanium Dioxide Trolamine Water Menthol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-02-24

Description

Camphor 0.5%

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Camphor 0.5%

Uses:

Temporary relief of itching associiated with minor skin irritations due to:

  • dry skin
  • insect bites
  • detergent
  • sunburn
Warnings
  • Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away
Warnings:
  • For external use only.
  • Avoid contact with eyes. In case of contact, flush thoroughly with water.
  • Stop use and ask a doctor if, condition worsens, symptoms last for more than 7 days, symptoms clear up and occur again within a few days
  • Do not use on deep puncture wounds, animal bites, or serious burns.
Questions?

Call 1-800-337-6296 Mon-Fri 9AM-5PM EST.

Directions:

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times dialy,

Children under 2 years of age: Consult a doctor

Active Ingredient

Camphor 0.5%

Other Infomation:

Store at room temperature (59°-86°F)

You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047

Inactive Ingredients:

water, Cetearyl Alcohol, PEG-40 Castor Oil, Sodium Cetearyl Sulfate, Stearic Acid, Glycol Stearate, Mineral Oil, Dimethicone, PEG-4 Dilaurate, Propylene Glycol, Imidazolidinyl Urea, Methylparaben, Propylparaben, Triethanolamine, Titanium Dioxide, menthol, Carbomer, Petrolatum, Disodium EDTA

Dermasarra Package Label Principal Display Panel


Structured Label Content

Uses:

Temporary relief of itching associiated with minor skin irritations due to:

  • dry skin
  • insect bites
  • detergent
  • sunburn
Purpose

External Analgesic

Warnings
  • Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away
Warnings:
  • For external use only.
  • Avoid contact with eyes. In case of contact, flush thoroughly with water.
  • Stop use and ask a doctor if, condition worsens, symptoms last for more than 7 days, symptoms clear up and occur again within a few days
  • Do not use on deep puncture wounds, animal bites, or serious burns.
Questions?

Call 1-800-337-6296 Mon-Fri 9AM-5PM EST.

Directions:

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times dialy,

Children under 2 years of age: Consult a doctor

Active Ingredient

Camphor 0.5%

Other Infomation:

Store at room temperature (59°-86°F)

You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047

Inactive Ingredients:

water, Cetearyl Alcohol, PEG-40 Castor Oil, Sodium Cetearyl Sulfate, Stearic Acid, Glycol Stearate, Mineral Oil, Dimethicone, PEG-4 Dilaurate, Propylene Glycol, Imidazolidinyl Urea, Methylparaben, Propylparaben, Triethanolamine, Titanium Dioxide, menthol, Carbomer, Petrolatum, Disodium EDTA

Dermasarra Package Label Principal Display Panel (DermaSarra Package Label Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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