Vaniply Ointment

Drug Labeling and Warnings

Drug Details [pdf]

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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 45334-600
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 45334-600-0270 g in 1 TUBE; Type 0: Not a Combination Product02/24/201106/30/2019
2NDC: 45334-600-01368 g in 1 JAR; Type 0: Not a Combination Product02/24/201109/30/2017
3NDC: 45334-600-055 g in 1 TUBE; Type 0: Not a Combination Product02/24/201109/30/2015
4NDC: 45334-600-144 g in 1 TUBE; Type 0: Not a Combination Product03/03/201404/30/2018
5NDC: 45334-600-351 in 1 CARTON02/19/201403/31/2019
510 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/24/201106/30/2019
Labeler - Pharmaceutical Specialties, Inc. (076499557)
Registrant - Pharmaceutical Specialties, Inc. (076499557)
Establishment
NameAddressID/FEIBusiness Operations
Pharmaceutical Specialties, Inc.076499557manufacture(45334-600)

Revised: 7/2017