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

• temporarily protects and helps relieve chapped or cracked skin

Warnings

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.

Directions

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, Phenoxyethanol , Xanthan Gum, Fragrance, Limonene, Caprylyl Glycol, Allantoin, Persea Gratissima (Avocado) Oil, Tocopheryl Acetate, Phytosterols, Ethylhexylglycerin, Hexylene Glycol, Panthenol, Olea Europaea (Olive) Fruit Oil, Disodium EDTA, Linalool

SPL UNCLASSIFIED SECTION

Questions?Call 1-800-551-2345 or visit www.jafra.com

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)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

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 - Distribuidora Comercial Jafra, S.A. de C.V. (951612777)

Registrant - Jafra Cosmetics International Inc (031183599)

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