SKIN SAKE- petrolatum ointment

SKIN SAKE by

Drug Labeling and Warnings

SKIN SAKE by is a Otc medication manufactured, distributed, or labeled by Skin Sake, LLC, Memphis Contract Packaging, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SKIN SAKE 
petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43447-2071
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	23 g  in 71 g

Inactive Ingredients
Ingredient Name	Strength
BALSAM PERU (UNII: 8P5F881OCY)
ALOE (UNII: V5VD430YW9)
BORIC ACID (UNII: R57ZHV85D4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ZINC OXIDE (UNII: SOI2LOH54Z)
MINERAL OIL (UNII: T5L8T28FGP)
CASTOR OIL (UNII: D5340Y2I9G)
WHITE WAX (UNII: 7G1J5DA97F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43447-2071-1	71 g in 1 TUBE
2	NDC: 43447-2071-0	100 in 1 BOX
2	NDC: 43447-2071-2	2 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	12/01/2005

Labeler - Skin Sake, LLC (195912717)

Registrant - Skin Sake, LLC (195912717)

Establishment
Name	Address	ID/FEI	Business Operations
Memphis Contract Packaging, Inc.		185390010	manufacture(43447-2071)