SALLY HANSEN CRACKED HEEL REPAIR CREME 24 HR MOISTURE- dimethicone cream 
Coty US LLC

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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Active Ingredient


Dimethicone 1%

Purpose

Skin protectant

Keep out of reach of children

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

Uses

Temporarily protects chapped or cracked skin

Warnings

For external use only

When using this product do not get into eyes

Stop use and ask a doctor if:

Directions

Apply and massage into feet daily, or as needed.

Do not use on

Inactive Ingredients

Aqua/Water/Eau, Paraffinum Liquidum/Mineral Oil/Huile Minerale, Carthamus Tinctorius (Safflower) Seed Oil, Petrolatum, Palmitic Acid, Stearic Acid, Glycerin, Butyrospermum Parkii (Shea) Butter, Cetyl Alcohol, Isopropyl Lanolate, Isopropyl Palmitate, Sorbitan Stearate, Phenoxyethanol, Parfum/Fragrance, Potassium Hydroxide, Methylparaben, Tocopheryl Acetate, Allantoin, Urea, Disodium Edta, Propylparaben, C12-15 Alkyl Benzoate, Limonene, Myristic Acid, Lineoleamidopropyl PG-Dimonium Chloride Phosphate, Sodium PCA, Ethylparaben, Propylene Glycol, Tribehenin, Linalool, Hydrolyzed Keratin, Magnesium Ascorbyl Phosphate, Retinyl Palmitate, Hexyl Cinnamal, Butylphenyl Methylpropinoal, Glycine Soja (Soybean) Seed Extract, Sodium Sulfate, Citral, Ceramide 2, Aloe Barbadensis Leaf Extract, Soluble Collagen, Coumarin, PEG-10 Rapeseed Sterol, Geraniol, Citronellol, Imdazolidnyl Urea, Potassium Sorbate, Benzoic Acid, Sodium Benzoate, Tocopherol, BHT, Palmitoyl Oligopeptide, FD&C Yello No. 5, FD&C Yello N

Outer Package

SALLY HANSEN CRACKED HEEL REPAIR CREME  24 HR MOISTURE
dimethicone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66184-152
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 1.133 g  in 113 g
Inactive Ingredients
Ingredient Name Strength
Water (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
PETROLATUM (UNII: 4T6H12BN9U)  
PALMITIC ACID (UNII: 2V16EO95H1)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
SHEANUT OIL (UNII: O88E196QRF)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALLANTOIN (UNII: 344S277G0Z)  
UREA (UNII: 8W8T17847W)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
MYRISTIC ACID (UNII: 0I3V7S25AW)  
LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE (UNII: 7461U1YLB7)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW) (UNII: ZR28QKN0WT)  
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SOYBEAN (UNII: L7HT8F1ZOD)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
CERAMIDE 2 (UNII: C04977SRJ5)  
PEG-10 RAPESEED STEROL (UNII: 258O76T85M)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SHEA BUTTER (UNII: K49155WL9Y)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
Citral (UNII: T7EU0O9VPP)  
CERAMIDE 2 (UNII: C04977SRJ5)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
COUMARIN (UNII: A4VZ22K1WT)  
GERANIOL (UNII: L837108USY)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:66184-152-02 1 in 1 BOX
1 NDC:66184-152-01 113 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part332 01/01/2012
Labeler - Coty US LLC (789573201)
Establishment
Name Address ID/FEI Business Operations
Process Technologies and Packaging Inc. 809172885 manufacture(66184-152)

Revised: 2/2013
Document Id: bd4d2e9c-b655-4474-9da1-f915cbb08131
Set id: 5a2d543d-043a-4b4b-b4df-ff17597171ff
Version: 1
Effective Time: 20130211
 
Coty US LLC