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Dosage form: ointment
Ingredients: DIMETHICONE 10mg in 1g
Labeler: Pharmaceutical Specialties, Inc.
NDC Code: 45334-600

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.

Drug Facts

Active ingredient(s)

Dimethicone 1%

Purpose

Skin Protectant

Use(s)
  • 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

When using this product
  • do not get into eyes

Stop use and ask 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 or puncture wounds
  • animal bites
  • serious burns

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

1-800-325-8232

www.psico.com

Principal Display Panel

Vaniply ointment

VANIPLY  
dimethicone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45334-600
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
C30-45 OLEFIN 
HYDROGENATED POLYDECENE (550 MW) 
MICROCRYSTALLINE WAX 
HIGH DENSITY POLYETHYLENE 
C30-45 ALKYL METHICONE  
Packaging
#Item CodePackage Description
1NDC:45334-600-0270 g in 1 TUBE
2NDC:45334-600-01368 g in 1 JAR
3NDC:45334-600-055 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34702/24/2011
Labeler - Pharmaceutical Specialties, Inc. (076499557)
Registrant - Pharmaceutical Specialties, Inc. (076499557)
Establishment
NameAddressID/FEIOperations
Pharmaceutical Specialties, Inc.076499557manufacture

Revised: 01/2012
Document Id: 5abb70b8-7c34-4a1b-ad7e-eec0c41628e8
Set id: 53f53dc6-21e3-4f55-bc0f-b0615dd8c8cf
Version: 1
Effective Time: 20120116
 
Pharmaceutical Specialties, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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