DIABETICS FOOT CREAM 4 OZ- dimethicone, petrolatum lotion 
BRANDS INTERNATIONAL

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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KISSABLE -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.

Inactive Ingredients Water, Ceterayl Alcohol, Glycerin, Isopropyl Myristate, DMDM Hydantoin, Carbomer, Sodium Hydroxide, Aloe Vera Leaf , Vitamin E.

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DIABETICS FOOT CREAM  4 OZ
dimethicone, petrolatum lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-610
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
LAURETH-7 (UNII: Z95S6G8201)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CARBOMER 1342 (UNII: 809Y72KV36)  
.ALPHA.-ELEOSTEARIC ACID (UNII: 934U1Q8QHG)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
VITAMIN E POLYETHYLENE GLYCOL SUCCINATE (UNII: O03S90U1F2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50157-610-11113 g in 1 TUBE; Type 0: Not a Combination Product02/22/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/22/2023
Labeler - BRANDS INTERNATIONAL (243748238)
Registrant - BRANDS INTERNATIONAL (243748238)
Establishment
NameAddressID/FEIBusiness Operations
BRANDS INTERNATIONAL243748238manufacture(50157-610)

Revised: 2/2023
Document Id: f54f9c1f-9852-25a5-e053-2995a90a444f
Set id: f54fffd8-6a24-761f-e053-2a95a90a3a10
Version: 2
Effective Time: 20230222
 
BRANDS INTERNATIONAL