VANICREAM DIAPER RASH- dimethicone, zinc oxide 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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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 Box

VANICREAM DIAPER RASH 
dimethicone, zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45334-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE11 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION400 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
C30-45 ALKYL METHICONE (UNII: NFX970DSI2)  
C30-45 OLEFIN (UNII: 6DWD51M0O8)  
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45334-301-021 in 1 CARTON06/30/201403/31/2019
170 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:45334-301-3510 g in 1 TUBE; Type 0: Not a Combination Product06/30/201403/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/30/201403/31/2019
Labeler - Pharmaceutical Specialties, Inc. (076499557)
Establishment
NameAddressID/FEIBusiness Operations
Pharmaceutical Specialties, Inc.076499557manufacture(45334-301) , pack(45334-301) , label(45334-301)

Revised: 5/2018
 
Pharmaceutical Specialties, Inc.