Vaniply Ointment, Improved Formula

Manufacturer
Pharmaceutical Specialties, Inc.
Effective date
2019-10-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:08:26

Label at a glance#

ProductVaniply
Active ingredientDIMETHICONE
Label structure15 sections

Storage and handling

Other information store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Dimethicone, 2%

OTC - PURPOSE SECTION

Purpose

Skin Protectant

INDICATIONS & USAGE SECTION

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 SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

OTC - WHEN USING SECTION

When using this product

  • do not get into eyes

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

Directions

  • apply as needed

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature

INACTIVE INGREDIENT SECTION

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

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

PACKAGE LABEL.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)

Vaniply_Jar 06-17Vaniply_Jar 06-17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45334-601-02GM - Gram45334-601d1246331-fae9-498e-b089-98b13f37a45312018-04-19

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
45334-60145334-601-02, 45334-601-01, 45334-601-14, 45334-601-32

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
94530b47-31d8-688c-e053-2a95a90ab129522db1e5-081e-70aa-e054-00144ff8d46c2019-10-07WarningsExact identifier
spl id: 94530b47-31d8-688c-e053-2a95a90ab129
spl set id: 522db1e5-081e-70aa-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.