VANIPLY - dimethicone ointment
Pharmaceutical Specialties, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Vaniply Ointment

Drug Facts

Active ingredient

Dimethicone, 1%

Purpose

Skin Protectant

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

For external use only

Do not use on

deep or puncture wounds
animal bites
serious burns

When using this product

do not get into eyes

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

Directions

apply as needed

Other information

store at room temperature

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

Questions?

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

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

Gluten-free.

Vanicream™ and Vaniply™ are trademarks or registered trademarks of Pharmaceutical Specialties, Inc. in the US or other countries.

PHARMACEUTICAL SPECIALTIES, INC.

ROCHESTER, MN 55901 USA

NDC 45334-600-02

From the makers of Vanicream™ Skin Cream

Vaniply™ Ointment

Skin Protectant/Dry Skin Care

DERMATOLOGIST RECOMMENDED

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

Net Wt 2.5 oz (70 g)

Vaniply AT16A

VANIPLY
dimethicone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:45334-600
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:45334-600-02	70 g in 1 TUBE; Type 0: Not a Combination Product	02/24/2011	06/30/2019
2	NDC:45334-600-01	368 g in 1 JAR; Type 0: Not a Combination Product	02/24/2011	09/30/2017
3	NDC:45334-600-05	5 g in 1 TUBE; Type 0: Not a Combination Product	02/24/2011	09/30/2015
4	NDC:45334-600-14	4 g in 1 TUBE; Type 0: Not a Combination Product	03/03/2014	04/30/2018
5	NDC:45334-600-35	1 in 1 CARTON	02/19/2014	03/31/2019
5		10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	02/24/2011	06/30/2019

Labeler - Pharmaceutical Specialties, Inc. (076499557)

Registrant - Pharmaceutical Specialties, Inc. (076499557)

Name	Address	ID/FEI	Business Operations
Establishment
Pharmaceutical Specialties, Inc.		076499557	manufacture(45334-600)

Revised: 7/2017

Document Id: 5499839e-49f3-62e1-e054-00144ff8d46c

Set id: 53f53dc6-21e3-4f55-bc0f-b0615dd8c8cf

Version: 3

Effective Time: 20170718

Pharmaceutical Specialties, Inc.