SELAN DF DIABETICS FOOT CARE- selan df diabetics foot care cream 
Trividia Manufacturing Solutions, 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.

----------

Selan DF Diabetics Foot Care

Active Ingredient

Dimethicone 5%

Purpose

Skin protectant

Uses

helps relieve, prevent and temporarily protect chafed, chapped, or cracked skin. helps protect from the drying effects of wind and cold weather.

Warnings

For external use only

When using this product

avoid contact with eyes

Stop use and ask a doctor if

condition worsens. symptoms persist for more than 7 days or clear up and occur again within a few days

Do not use on

deep or puncture wounds. animal bites. serious burns

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

apply as needed to dry, rough, or problem skin areas. reapply as often as needed

Inactive Ingredients

water, ethylhexyl palmitate, glyceryl tribehenate, glycerin, stearic acid, cetearyl alcohol, behenyl erucate, octyldodecyl behenate, caprylyl glycol, phenoxyethanol, hexylene glycol, tocopheryl acetate, allantoin, carbomer, bisabolol, zingiber officinale (ginger) root extract, cholesterol, disodium EDTA, aloe barbadensis leaf juice, sodium hydroxide

SPL Unclassified Section

Distributed by: Span America

Span-America Medical Systems, Inc.

70 Commerce Center,

Greenville, SC 29615 800-888-6752

Package Label

Selan DF Foot Cream

SELAN DF DIABETICS FOOT CARE 
selan df diabetics foot care cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0159-7750
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
BEHENYL ERUCATE (UNII: 681898L9A8)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
LEVOMENOL (UNII: 24WE03BX2T)  
GINGER (UNII: C5529G5JPQ)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALLANTOIN (UNII: 344S277G0Z)  
OCTYLDODECYL BEHENATE (UNII: BZM9WE5P6F)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0159-7750-04113.4 g in 1 TUBE; Type 0: Not a Combination Product07/07/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/07/201707/31/2020
Labeler - Trividia Manufacturing Solutions, Inc (018927392)

Revised: 12/2020
 
Trividia Manufacturing Solutions, Inc