PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT- dimethicone cream

Pro Advantage Fast Absorbing Perineal with Dimethicone Skin Protectant by

Drug Labeling and Warnings

Pro Advantage Fast Absorbing Perineal with Dimethicone Skin Protectant by is a Otc medication manufactured, distributed, or labeled by NDC National Distribution & Contracting, Inc., Dukal. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

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

Product Labels

INGREDIENTS AND APPEARANCE

PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43128-035
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43128-035-02	1 in 1 PACKAGE	03/07/2013
1		118 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/07/2013

Labeler - NDC National Distribution & Contracting, Inc. (009831413)

Establishment
Name	Address	ID/FEI	Business Operations
Dukal		865792209	manufacture(43128-035)