Skin Sake
FDA Label NDC 43447-2071

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Skin Sake, Llc for the product Skin Sake (NDC 43447-2071). 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, keep out of reach of children, uses, warnings, directions, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Drug Facts

Active Ingredient

White Petrolatum

Purpose

Soothes, Treats, Prevents,

Skin Irritations
Chafed Areas
Incontinent Rashes
Pressure Sores


Keep Out Of Reach Of Children

Keep out of reach of children.

Uses

  • Helps soothe, treat , and prevent skin breakdown
  • Repels wetness
  • Protects delicate skin
  • Relieves chapped, moist or irritated areas
  • Prevents Friction

Warnings

For external use only.

When using this product, do not get into eyes.

Stop and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

Do not use on deep puncture wounds, animal bites, serious burns.

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

Directions



Cleanse and dry area.Apply a thin layer to skin as often as necessary.
Store between 15° - 30° C, (59° - 86° F)

Inactive Ingredients

Peruvian Balsam, Aloe, Acidum Boricum, Vitamin E (Tocopherol), Zinc Oxide,  Mineral Oil, Castor Oil, White Beeswax.

Product Label

NDC # 43447-2071-1

SKIN®Sake ointment

Soothes, Treats, Prevents
Skin Irritations
Chafed Areas
Incontinence Rashes
Pressure Sores

Skin Protectant
Moisture Barrier
Aloe and Vit. E Added
with Natural Peruvian Balsam

Net Wt 2.5 oz (71g)

Manufactured by:
SKIN SAKE, LLC
P.O. Box 390, Hamburg, AT 71646

1-888-853-5544  skinsake.com

Ss Skinsake Label (Ss Skinsake)

Ss Skinsake Label (Ss Skinsake)

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