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Pro Advantage Fast Absorbing Perineal with Dimethicone Skin Protectant

Dosage form: cream
Ingredients: DIMETHICONE 20mg in 1mL
Labeler: NDC National Distribution & Contracting, Inc.
NDC Code: 43128-035

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.

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

PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43128-035
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
MINERAL OIL 
GLYCERIN 
PROPYLENE GLYCOL 
MEDIUM-CHAIN TRIGLYCERIDES 
POLYSORBATE 60 
CETYL ALCOHOL 
GLYCERYL MONOSTEARATE 
SORBITAN MONOSTEARATE 
TROLAMINE 
ALLANTOIN 
DIAZOLIDINYL UREA 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:43128-035-021 TUBE in 1 PACKAGE
1118 mL in 1 TUBE
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/FEIOperations
Dukal865792209manufacture(43128-035)

Revised: 01/2018
 
NDC National Distribution & Contracting, 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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