Skin Sake Surface Protectant
FDA Label NDC 43447-4410

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 Surface Protectant (NDC 43447-4410). 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

Dimethicone 2%

Purpose

Skin Protectant

Keep Out Of Reach Of Children

Keep out of reach of children.

Uses

  • Helps soothe, treat, and prevent ulcer-prone areas, cracked skin, rashes
  • Repels wetness
  • Protects delicate skin
  • Relieves chapped, moist 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 or punctured wounds, animal bites, serious burns.

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

Directions

Cleanse and dry area. Apply liberally as often as necessary, at least 4 or 5 times per day. Re-apply as needed.

Store between 15° -30° C, (59° -86° F)

Inactive Ingredients

Aloe Barbadensis Extract, Acidium Boricum, Castor Oil, Cholecalciferol (Vitamin D), Cod Liver Oil, Green 6, Microcrystalline Wax, Mineral Oil, Myroxylon pereirae (Balsam Peru) Resin, Red 17, Vitamin A, Vitamin E, White Petrolatum, White Wax, Yellow 11

Product Label

www.skinsake.com


SKIN SAKE

Surface Protectant

PHARMACIST FORMULATED

Soothes and Prevents:

Ulcer-Prone Areas
Reddened/Cracked Skin
Incontinent Rashes
Chafed Areas

Repels Wetness
Vitamin A, D, E, and Aloe

NET WT 4OZ  SP02

Manufactured for:

Skin Sake

P.O. Box 390

Hamburg, AR 71646

1-888-853-5544

681441-00

Ss Surface-protectant Label (Ss Surface Protectant)

Ss Surface-protectant Label (Ss Surface Protectant)

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