PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT- dimethicone cream 
NDC National Distribution & Contracting, 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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Pro Advantage Fast Absorbing Perineal with Dimethicone Skin Protectant

Drug Facts


Active Ingredient

Dimethicone 2%

Purpose

Skin Protectant

Uses

Temporarily protects • and helps relieve chapped or cracked skin

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:

• gently cleanse and dry affected area • apply liberally to affected area as needed.

Inactive Ingredients

Water, Mineral Oil, Glycerin, Propylene Glycol, Caprylic/Capric Triglyceride, Polysorbate 60, Cetyl Alcohol, Glyceryl Stearate, Sorbitan Stearate, Carbomer, Triethanolamine, Allantoin, Diazolidinyl Urea, Methylparaben, Propylparaben, Fragrance

REF: P770035 NDC 43128-035-03

Made in China
www.ProAdvantagebyNDC.com

Manufactured for NDC, Inc.
407 New Sanford Road, La Vergne, TN 37086

Pro ADVANTAGE Fast Absorbing by NDC
Perineal Cream with Dimethicone
4FL.OZ ( 118 mL )
Skin Protectant

Product Labels

Perineal Label 1Perineal Label 2

PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43128-035
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALLANTOIN (UNII: 344S277G0Z)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43128-035-021 in 1 PACKAGE03/07/2013
1118 mL in 1 TUBE; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/07/2013
Labeler - NDC National Distribution & Contracting, Inc. (009831413)
Establishment
NameAddressID/FEIBusiness Operations
Dukal865792209manufacture(43128-035)

Revised: 2/2019
Document Id: 8152e11f-403b-f83c-e053-2a91aa0a0f4d
Set id: d4f3df9f-94c4-49c5-94cd-4b97ec254993
Version: 4
Effective Time: 20190207
 
NDC National Distribution & Contracting, Inc.