BATH AND BEAUTY DIABETICS FOOT CREAM- dimethicone, petrolatum lotion 
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI

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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Bath & Beauty Diabetics' Foot Cream

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

Do not use on

deep or puncture wounds
animal bites
serious burns

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.

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

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BATH AND BEAUTY  DIABETICS FOOT CREAM
dimethicone, petrolatum lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76772-026
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:76772-026-11113 g in 1 TUBE; Type 0: Not a Combination Product03/10/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/10/2021
Labeler - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)
Registrant - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)
Establishment
NameAddressID/FEIBusiness Operations
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI533120570manufacture(76772-026)

Revised: 3/2021
Document Id: bd3aecf5-37f8-53d6-e053-2a95a90a83db
Set id: 4a1606ec-65ad-466f-b309-204ee9030d76
Version: 2
Effective Time: 20210310
 
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI