Dermagreen Skin Care
FDA Label NDC 83363-003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Healthy Gourmet Plus, Inc for the product Dermagreen Skin Care (NDC 83363-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Allantoin 1%

Lidocaine 1%

Purpose

Skin Protectant

External Analgesic

Uses

  • for the temporary relief of pain associated with minor burns or minor skin irritations
  • temporarily protects minor
  • cuts
  • scrapes
  • burns
  • temporarily protects chapped or cracked skin

Warnings

For external use only.

Do Not Use

  • on deep or puncture wounds
  • on animal bites
  • on serious burns
  • in large quantities, particularly over raw surfaces or blistered areas

When Using This Product

do not get into eyes.

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children over 12 years: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period.
  • Children under 12 years: ask a doctor.

Inactive Ingredients

African oil palm oil, almond oil, alpha-tocopheryl acetate, beeswax, bitter orange extract, buckthorn oil, C10-18 triglyceride, carrot root extract, evening primrose oil, frankincense extract, geranium extract, hydrogenated coconut oil, lavender extract, lemongrass extract, paraffin wax, patchouli oil, shea butter, stearic acid, sunflower oil, wheat germ oil, white flower oil, ylang-ylang extract.

Package Labeling:

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