Hand Essentials Skin Repair
FDA Label NDC 65626-161

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hu-friedy Mfg. Co., Inc. for the product Hand Essentials Skin Repair (NDC 65626-161). 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 ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Dimethicone 1.5%

Purpose

Skin protectant

Uses

  • Temporarily protects and helps relieve chapped or cracked skin. Beneficial for face, hands, body and legs.

Warnings

For External Use Only.

Do Not Use

  • on deep or puncture wounds
  • on animal bites
  • on serious burns

When Using This Product

  • do not get into eyes.

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms last for 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

  • Apply cream liberally as needed.

Other Information

  • Protect from freezing. Avoid excessive heat.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Ascorbic Acid, Ascorbyl Palmitate, Canola Oil, Cetyl Alcohol, Cholecalciferol, Citric Acid, Citrus Aurantium Dulcis Peel Oil, Citrus Grandis Peel Oil, Citrus Tangerina Peel Oil, Diazolidinyl Urea, Glycerin, Glyceryl Stearate SE, Glycine, Hydroxytyrosol, L-proline, L-taurine, Methylparaben, Methylsulfonylmethane, N-acetyl-L-cysteine, Niacinamide, Olea Europaea Fruit Oil, PEG-8, PEG-100 Stearate, Propylene Glycol, Propylparaben, Pyridoxine HCI, Retinyl Palmitate, Stearic Acid, Stearyl Alcohol, Tetrasodium EDTA, Tocopherol, Triethanolamine, Vanillin, Water, Zea Mays Oil.

Package/Label Principal Display Panel

Hu-friedy Hand Essentials Skin Repair Cream (D102e331 Fd3f 46ca 9382 2f103afbc853 01)

Hu-friedy Hand Essentials Skin Repair Cream (D102e331 Fd3f 46ca 9382 2f103afbc853 01)

Hu-Friedy

HAND ESSENTIALS

Skin Repair Cream

Every Day Moisturizer

with Olivamine

  • Nourishes and conditions dry, cracked skin
  • Non-allergenic
  • Non-sensitizing
  • CHG & latex friendly

    • Part-code: IMS-1502

    Hu-Friedy

    2 Fl oz (59 mL)

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