SPA DRY HEEL FOOT RELIEF- dimethicone cream

Spa Dry Heel Foot Relief by

Drug Labeling and Warnings

Spa Dry Heel Foot Relief by is a Otc medication manufactured, distributed, or labeled by Jafra Cosmetics International Inc, Distribuidora Comercial Jafra, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Dimethicone 4%

Purpose

Skin protectant

Uses

• Helps prevent and temporarily protects chapped or cracked skin

Warning

For external use only
When using this product● do not get into eyes
Stop use and ask a doctor● condition worsens ● symptoms last more than 7 days or clear up and occur again in a few days
Do not use on● deep or puncture wounds ● animal bites ● serious burns
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Direction

apply as needed

KEEP OUT OF REACH OF CHILDREN

Inactive ingredients

Water, Caprylic/Capric Triglyceride, Glycerin, Polyisobutene, Butyrospermum Parkii (Shea) Butter, Stearyl Stearate, Isopropyl Palmitate, Cetearyl Alcohol, Cetyl Alcohol, Di-PPG-3 Myristyl Ether Adipate, Myristyl Myristate, Ceteareth-20, Behenyl Alcohol, Niacinamide, Sodium PCA, Lactic Acid, Olea Europaea (Olive) Fruit Oil, Fragrance, Phenoxyethanol, Xanthan Gum, Caprylyl Glycol, Allantoin, Persea Gratissima (Avocado) Oil, Tocopheryl Acetate, Phytosterols, Ethylhexylglycerin, Hexylene Glycol, Panthenol, Disodium EDTA

Product label

INGREDIENTS AND APPEARANCE

SPA DRY HEEL FOOT RELIEF 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-002
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
POLYISOBUTYLENE (55000 MW) (UNII: TQ77WR8A02)
SHEA BUTTER (UNII: K49155WL9Y)
STEARYL STEARATE (UNII: 5WX2EGD0DK)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
DOCOSANOL (UNII: 9G1OE216XY)
NIACINAMIDE (UNII: 25X51I8RD4)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
OLIVE OIL (UNII: 6UYK2W1W1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALLANTOIN (UNII: 344S277G0Z)
AVOCADO OIL (UNII: 6VNO72PFC1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PANTHENOL (UNII: WV9CM0O67Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-002-01	1 in 1 CARTON	06/01/2022
1		115 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	06/01/2022

Labeler - Jafra Cosmetics International Inc (041676479)

Registrant - Jafra Cosmetics International Inc (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Distribuidora Comercial Jafra, S.A. de C.V.		951612777	manufacture(68828-002)