Glo Skin Beauty Remedy Gel
FDA Label NDC 60541-1900

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hayden Caleel Llc for the product Glo Skin Beauty Remedy Gel (NDC 60541-1900). 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 active ingredients, purpose, uses, warnings, keep out of reach of children, directions, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Hydrocortisone 1%

Purpose

Anti-itch

Uses

  • temporarily relieves itching associate with minor skin irritations, inflammation an rashes due to:
  • dermatitis, exzema, insect bites
  • other uses of this prouct should be only under the advice and supervision of a doctor

Warnings

For external use only

Do not use

  • for the treatment of iaper rash. Ask a doctor

    • When using this product
    • avoid contact with the eyes
    • do not use more than directed unless told to do so by a doctor

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hyrdrocortisone product unless you have asked a doctor

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.

Directions

  • for itching of skin irritation, inflamation and rashes
  • adults an chilren 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: do not use, ask a doctor

Inactive Ingredients

Aqua (Water), Glycerin, Caprylic/Capric Triglyceride, Cetearyl Olivate, Rosa Canina (Rose Hip) Fruit Oil, Squalane, Sorbitan Olivate, Bisabolol, Carbomer, Gluconolactone, Lonicera Caprifolium (Honeysuckle) Flower Extract, Hedychium Coronarium (White Ginger) Root Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Sodium Benzoate, Phenethyl Alcohol, Potassium Sorbate, Caprylyl Glycol, Tocopherol, Glycine Soja (Soybean) Oil, Aloe Barbadensis Leaf Juice Powder, Phytic Acid, Sodium Hydroxide, Xanthan Gum, Trisodium Ethylenediamine Disuccinate

Principal Display Panel

541-1900-3 (60541 1900 3)

541-1900-3 (60541 1900 3)

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