Your browser does not support JavaScript! SALLY HANSEN CRACKED HEEL REPAIR CREME 24 HR MOISTURE (DIMETHICONE) CREAM [COTY US LLC]
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SALLY HANSEN CRACKED HEEL REPAIR CREME 24 HR MOISTURE (dimethicone) cream
[Coty US LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 DRUG LABELItem Code (Source)NDC:66184-152
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE1.133 g  in 113 g
Inactive Ingredients
Ingredient NameStrength
Water 
MINERAL OIL 
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES 
PETROLATUM 
PALMITIC ACID 
STEARIC ACID 
GLYCERIN 
CETYL ALCOHOL 
ISOPROPYL PALMITATE 
SORBITAN MONOSTEARATE 
SHEANUT OIL 
POTASSIUM HYDROXIDE 
METHYLPARABEN 
ALPHA-TOCOPHEROL ACETATE 
ALLANTOIN 
UREA 
EDETATE DISODIUM 
PROPYLPARABEN 
C12-15 ALKYL BENZOATE 
MYRISTIC ACID 
LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE 
SODIUM PYRROLIDONE CARBOXYLATE 
ETHYLPARABEN 
PROPYLENE GLYCOL 
TRIBEHENIN 
LINALOOL, (+/-)- 
HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW) 
MAGNESIUM ASCORBYL PHOSPHATE 
VITAMIN A PALMITATE 
SOYBEAN 
SODIUM SULFATE 
CERAMIDE 2 
PEG-10 RAPESEED STEROL 
POTASSIUM SORBATE 
BENZOIC ACID 
SODIUM BENZOATE 
TOCOPHEROL 
BUTYLATED HYDROXYTOLUENE 
PALMITOYL OLIGOPEPTIDE 
PHENOXYETHANOL 
CITRIC ACID MONOHYDRATE 
FD&C YELLOW NO. 5 
FD&C YELLOW NO. 6 
SHEA BUTTER 
.ALPHA.-HEXYLCINNAMALDEHYDE 
Citral 
CERAMIDE 2 
ALOE VERA LEAF 
COUMARIN 
GERANIOL 
.BETA.-CITRONELLOL, (R)- 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66184-152-021 in 1 BOX
1NDC:66184-152-01113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33201/01/2012
Labeler - Coty US LLC (789573201)
Establishment
NameAddressID/FEIBusiness Operations
Process Technologies and Packaging Inc.809172885manufacture(66184-152)

Revised: 2/2013
 
Coty US LLC

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