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:

  • condition worsens
  • symptoms last for more than 7 days or clear up and occur again within a few days

Directions

Apply and massage into feet daily, or as needed.

Do not use on

  • Deep or puncture wounds
  • Animal bites
  • Serious burns

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:66184-152
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.133 g  in 113 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
CARTHAMUS TINCTORIUS SEED 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)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
MYRISTIC ACID (UNII: 0I3V7S25AW)  
LINOLEAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE (UNII: 7461U1YLB7)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW) (UNII: ZR28QKN0WT)  
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SOYBEAN (UNII: L7HT8F1ZOD)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
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 HEXAPEPTIDE-12 (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 NG (UNII: C04977SRJ5)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
COUMARIN (UNII: A4VZ22K1WT)  
GERANIOL (UNII: L837108USY)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66184-152-021 in 1 BOX01/01/201212/31/2017
1NDC:66184-152-01113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33201/01/201212/31/2017
Labeler - Coty US LLC (789573201)

Revised: 12/2018
 
Coty US LLC