SELAN PLUS ZINC OXIDE- zinc oxide and dimethicone cream 
PJ Noyes Co. 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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Selan Plus Zinc Oxide

Active Ingredients

Dimethicone 2.1%

Zinc Oxide 2%

Purpose

Skin Protectant

Uses

Warnings

For external use only

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Other Information:

Store at room temperature

Purified Water USP, Cetyl Alcohol, Sorbitol USP, Glycerol Monostearate, Sodium Lauryl Sulfate, Lanolin USP, Methylparaben, Fragrance, Quaternium-15, Propylparaben.

Image of 4oz tube
SelanTUBEimage.jpg

Selan 4oz tube image

Image of 16oz jar

Selan 16oz jar image

Image of 8ml packet

Selan 8ml packet image

SELAN PLUS ZINC OXIDE 
selan plus zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0159-2200
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 2.1   in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LANOLIN (UNII: 7EV65EAW6H)  
SORBITOL (UNII: 506T60A25R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
QUATERNIUM-15 (UNII: E40U03LEM0)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0159-2200-04 117 g in 1 TUBE
2 NDC:0159-2200-01 8.1 g in 1 PACKET
3 NDC:0159-2200-17 458 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 08/29/1997
Labeler - PJ Noyes Co. Inc. (018927392)
Establishment
Name Address ID/FEI Business Operations
PJ Noyes Co. Inc. 018927392 manufacture(0159-2200) , label(0159-2200) , pack(0159-2200)

Revised: 3/2013
Document Id: c2621ff6-9cc9-41d2-95f6-d3fda4f2d7a6
Set id: 07396c61-1dfd-4be7-bddf-0eb570a18463
Version: 1
Effective Time: 20130328
 
PJ Noyes Co. Inc.