Label: PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT- dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 43128-035-02 - Packager: NDC National Distribution & Contracting, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 7, 2019
If you are a consumer or patient please visit this version.
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- Drug Facts
- Active Ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
- Directions:
- Inactive Ingredients
- REF: P770035 NDC 43128-035-03
- PRINCIPAL DISPLAY PANEL
- Product Labels
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INGREDIENTS AND APPEARANCE
PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT
dimethicone creamProduct 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)