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Vanicream Diaper Rash

Dosage form: ointment
Ingredients: DIMETHICONE 11mg in 1g, ZINC OXIDE 400mg in 1g
Labeler: Pharmaceutical Specialties, Inc.
NDC Code: 45334-301

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.

VANICREAM Diaper Rash Ointment

Drug Facts

Active ingredients

Zinc Oxide, 40%

Dimethicone, 1.1%

Purpose

Skin Protectant

Skin Protectant

Uses
  • helps treat and prevent diaper rash
  • protects minor skin irritation associated with diaper rash
  • helps protect from wetness

Warnings

For external use only

When using this product

  • avoid contact with 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
  • change wet or soiled diapers promptly, clean the diaper area and allow to dry
  • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime exposure to wet diapers may be prolonged

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.psico.com

PHARMACEUTICAL SPECIALTIES, INC.

ROCHESTER, MN 55903-6298 USA

Vanicream is a trademark, or registered trademark, of Pharmaceutical Specialties, Inc. in the U.S. or other countries.

©PSI 2014. All rights reserved.

Vanicream™ Diaper Rash Ointment contains Zinc Oxide and Dimethicone, two complimentary active ingredients that together treat and prevent diaper rash, chafed skin and minor skin irritation. The maximum strength Zinc Oxide helps reduce the duration and severity of the rash. The Dimethicone provides additional protection and seals out wetness, helping to prevent reoccurrence.

Specially formulated for those who need, or want, to avoid common chemicals irritants found in ordinary diaper rash products. Recommended by pediatricians and dermatologist to help treat and prevent diaper rash. Ideal for even the most delicate or sensitive skin.

  • non-greasy
  • easy-to-spread
  • easily removed with a damp cloth
  • no messy clean-up
  • leaves skin soft and smooth
  • preservative-free
  • gluten-free

for Sensitive Skin

For information on our other products for sensitive skin, visit our website at www.vanicream.com or call 1-800 325-8232

VANICREAM™
Diaper Rash Ointment

NDC 45334-301-02

PEDIATRICIAN/DERMATOLOGIST RECOMMENDED

Kid Friendly

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

MAXIMUM STRENGTH

Net Wt 2.5 oz (70 g)

VANICREAM DIAPER RASH 
dimethicone, zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45334-301
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE11 mg  in 1 g
ZINC OXIDE (ZINC CATION) ZINC CATION400 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE WAX 
HIGH DENSITY POLYETHYLENE 
C30-45 ALKYL METHICONE 
C30-45 OLEFIN 
HYDROGENATED POLYDECENE (550 MW) 
SILICA DIMETHYL SILYLATE 
Packaging
#Item CodePackage Description
1NDC:45334-301-021 TUBE in 1 CARTON
170 g in 1 TUBE
2NDC:45334-301-3510 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/30/2014
Labeler - Pharmaceutical Specialties, Inc. (076499557)
Establishment
NameAddressID/FEIOperations
Pharmaceutical Specialties, Inc.076499557manufacture(45334-301), pack(45334-301), label(45334-301)

Revised: 09/2017
 
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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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