DIABETICS FOOT CREAM 4 OZ- dimethicone, petrolatum lotion 
Greenbrier International, 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.

----------

Diabetics' Foot Cream 4 oz

Active Ingredient Purpose

Dimethicone 1% ...... Skin Protectant

Petrolatum 30%........Skin Protectant

Skin protectant

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Use help prevent and temporarily protets chafed, chapped, or cracked skin.

Warnings For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush with water.

Do not use on

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.

Directions  apply liberally as often as needed.

Other information Store at room temperature.

DISTRIBUTED BY: 

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

MADE IN CHINA

Inactive Ingredients water, ceterayl alcohol, PEG-100 stearate, glycerin, glyceryl stearate, polyquaternium-22, c13-16 isoparaffin laureth-25,DMDM hydantoin, carbomer, polyacrylamide, c13-14 isoparaffin, laureth-7, panthenol, tocopheryl acetate

image

DIABETICS FOOT CREAM  4 OZ
dimethicone, petrolatum lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-3037
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
C13-16 ISOPARAFFIN (UNII: LED42LZG6O)  
LAURETH-7 (UNII: Z95S6G8201)  
POLYQUATERNIUM-22 (4500 MPA.S) (UNII: H3W1D31JAR)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
PANTHENOL (UNII: WV9CM0O67Z)  
PEG-100 STEARATE (UNII: YD01N1999R)  
LAURETH-25 (UNII: RPD53041LR)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-3037-1113 g in 1 TUBE; Type 0: Not a Combination Product12/16/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/16/2018
Labeler - Greenbrier International, Inc. (610322518)
Establishment
NameAddressID/FEIBusiness Operations
China Ningbo Shangge Cosmetic Technology Corp529287434manufacture(33992-3037)

Revised: 12/2018
Document Id: 7d60e8c9-abcb-8c92-e053-2a91aa0ac8a6
Set id: 7d60e8c9-abca-8c92-e053-2a91aa0ac8a6
Version: 1
Effective Time: 20181219
 
Greenbrier International, Inc.