VANIPLY- dimethicone ointment

Vaniply by

Drug Labeling and Warnings

Vaniply by is a Otc medication manufactured, distributed, or labeled by Pharmaceutical Specialties, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Dimethicone, 2%

PURPOSE

Purpose

Skin Protectant

INDICATIONS & USAGE

Uses

• helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin and lips
• helps prevent and protect from the drying effects of wind and cold weather

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

WHEN USING

When using this product

• do not get into eyes

STOP USE

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days

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

DOSAGE & ADMINISTRATION

Directions

• apply as needed

STORAGE AND HANDLING

Other information

• store at room temperature

INACTIVE INGREDIENT

Inactive ingredients C30-45 alkyl methicone, C30-45 olefin, hydrogenated polydecene, microcrystalline wax, polyethylene, silica dimethyl silylate

QUESTIONS

Questions?

1-800-325-8232 www.vanicream.com

SPL UNCLASSIFIED SECTION

Vaniply™ Ointment is a unique formulation that is easy-to-spread, non-greasy, and long-lasting. It protects and helps moisturize the skin.

Vanicream™ and Vaniply™ are trademarks or registered trademarks, of Pharmaceutical Specialties, Inc. in the US or other countries. © PSI 2010. All rights reserved.

PHARMACEUTICAL SPECIALTIES, INC.

ROCHESTER, MN 55901

Made in USA

PRINCIPAL DISPLAY PANEL

NDC: 45334-601-01

DERMATOLOGIST TESTED

From the makers of VANICREAM™ Skin Cream

Improved Formula

VANIPLY™ Ointment for Sensitive Skin

Skin Protectant/Dry Skin Care

Free of dyes, fragrance, masking fragrance, lanolin, parabens, formaldehyde & other preservatives

Non-comedogenic Gluten-free

Net Wt 13 oz (368 g)

INGREDIENTS AND APPEARANCE

VANIPLY  
dimethicone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45334-601
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
C30-45 OLEFIN (UNII: 6DWD51M0O8)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
C30-45 ALKYL METHICONE (UNII: NFX970DSI2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45334-601-02	70 g in 1 TUBE; Type 0: Not a Combination Product	08/07/2017	09/30/2020
2	NDC: 45334-601-01	368 g in 1 JAR; Type 0: Not a Combination Product	08/07/2017	09/30/2020
3	NDC: 45334-601-14	4 g in 1 TUBE; Type 0: Not a Combination Product	09/07/2017	07/31/2020
4	NDC: 45334-601-32	1 in 1 CARTON	08/07/2017	09/30/2020
4		9.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/07/2017	09/30/2020

Labeler - Pharmaceutical Specialties, Inc. (076499557)

Registrant - Pharmaceutical Specialties, Inc. (076499557)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaceutical Specialties, Inc.		076499557	manufacture(45334-601)