BATH AND BEAUTY DIABETICS FOOT CREAM- dimethicone, petrolatum lotion

Bath and beauty by

Drug Labeling and Warnings

Bath and beauty by is a Otc medication manufactured, distributed, or labeled by TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient Purpose

Dimethicone 1% ...... Skin Protectant

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

PURPOSE

Skin protectant

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

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

WARNINGS

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.

DOSAGE & ADMINISTRATION

Directions  apply liberally as often as needed.

OTHER SAFETY INFORMATION

Other information Store at room temperature.

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BATH AND BEAUTY  DIABETICS FOOT CREAM
dimethicone, petrolatum lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76772-026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	30 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76772-026-11	113 g in 1 TUBE; Type 0: Not a Combination Product	03/10/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/10/2021

Labeler - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)

Registrant - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)

Establishment
Name	Address	ID/FEI	Business Operations
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI		533120570	manufacture(76772-026)