DIABECARE GRISI DIABETICS FOOT CREAM- dimethicone cream
GRISI Hnos, S.A DE C.V

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Diabecare Grisi Diabetics Dry Skin Relief Foot Cream

Active Ingredients/Ingredientes Activos

Dimethicone/Dimeticona 3%

Purpose/Utilidad

Skin protectant/Protector de piel

Uses/Usos

■ Temporarily protects and helps relieve chafed or cracked skin/Protege temporalmente y ayuda a aliviar la piel irritada o agrietada

■ Helps protect from the drying effects of wind and cold weather / Ayuda a proteger de la resequedad causada por el viento y el clima frío

Warnings/Precauciones

■ For external use only / Sólo para uso externo

Do not use on/No usar en

■ Animal bites / Picaduras de animales ■ Deep or puncture wounds / Heridas profundas o punzantes ■ Serious burns /Quemaduras graves

When using this product/Cuando use este producto

■ Avoid contact with eyes/Evite el contacto con los ojos

Stop use and ask a doctor if / Suspenda su uso y consulte a su médico si

■ Condition worsens / La condición empeora

■ Symptoms last more than 7 days or clear up and occur again within a few days/Los síntomas persisten por más de 7 días o mejoran y vuelven a aparecer a los pocos días

Keep out of reach of children.

Manténgase fuera del alcance de los niños

Directions/Modo de uso

■ Apply generously to affected area as needed/Aplique generosamente sobre el area afectada según sea necesario

Inactive ingredients/Ingredientes inactivos

Water, Niacinamide, Cetearyl Alcohol, Isopropyl Palmitate, Shea Butter, Sorbitan Stearate, Petrolatum, Cetyl Alcohol, Glyceryl Stearate, Propanediol, Avocado Oil, Glycerin, PEG-75 Stearate, Ceteth-20, Steareth-20, Dragon´s Blood Resin Powder, Lactoferrin, Beeswax, Sorbitol, Lecithin, Xanthan Gum, Tetrasodium EDTA, BHT, Phenoxyethanol, Decylene Glycol, Caprylyl Glycol.

Questions or comments / ¿Preguntas o comentarios?

1-833-794-3320

To report adverse events or therapeutic failures, please contact us:

farmacovigilancia@grisi.com/www.grisius.com

Package Label

DIABECARE GRISI DIABETICS FOOT CREAM
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68437-014
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	3 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
DRAGON'S BLOOD (UNII: M3YJ2C28IC)
NIACINAMIDE (UNII: 25X51I8RD4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
SHEA BUTTER (UNII: K49155WL9Y)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CETYL ALCOHOL (UNII: 936JST6JCN)
AVOCADO OIL (UNII: 6VNO72PFC1)
PEG-75 STEARATE (UNII: OT38R0N74H)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETETH-20 (UNII: I835H2IHHX)
STEARETH-20 (UNII: L0Q8IK9E08)
YELLOW WAX (UNII: 2ZA36H0S2V)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DECYLENE GLYCOL (UNII: S57M60MI88)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EDETATE SODIUM (UNII: MP1J8420LU)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
LACTOFERRIN, BOVINE (UNII: KG21X1090A)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68437-014-02	1 in 1 BOX	07/08/2019	04/30/2022
1	NDC:68437-014-80	80 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	07/08/2019	04/30/2022

Labeler - GRISI Hnos, S.A DE C.V (810320754)

Name	Address	ID/FEI	Business Operations
Establishment
GRISI Hnos, S.A DE C.V		810320754	manufacture(68437-014)

Revised: 11/2023

Document Id: 0b66de73-748e-f3f1-e063-6294a90aba95

Set id: 8dfc6596-f45a-aaf0-e053-2a95a90a4c21

Version: 3

Effective Time: 20231130

GRISI Hnos, S.A DE C.V