POST-TREATMENT REPAIR CREAM- hydrocortisone cream 
Vi Medical Products Inc.

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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Post-Treatment Repair Cream

Active Ingredients: Purpose

Hydrocortisone 1% Anti-itch

Uses: For the temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps and detergents, cosmetics, jewelry.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Warnings: For external use only. Avoid contact with eyes. Do not use this or any other hydrocortisone products unless you have consulted a doctor.

Directions: Adults and children under 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: Do not use, consult a doctor

Inactive Ingredients:

Allantoin, Aloe Barbadensis Leaf Juice, Beta Glucan, Bisabolol (and)Zingiber Officinale (Ginger) Root Extract, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Coco-Glucoside (and) Coconut Alcohol, Colloidal Silver, Dimethicone, Ethylhexyl Palmitate, Glycerin, Glyceryl Stearate (and) PEG-100 Stearate, Myristyl Myristate, Panthenol, Pentylene Glycol (and) 4-t-Butylcyclohexanol Phenoxyethanol (and) Ethylhexylglycerin, Purified Water, Sclerocarya Birrea Seed Oil, Sodium Polyacrylate, Tocopherol Acetate

Other Information: Store at 20°C (66° – 77°F)

VI Derm Beauty

Post-Treatment Repair Cream

Anti-itch Cream

Hydrocortisone 1%

1 FL OZ / 30 mL

Post repair cream antiitch

POST-TREATMENT REPAIR CREAM 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70484-105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)  
GINGER (UNII: C5529G5JPQ)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LEVOMENOL (UNII: 24WE03BX2T)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCONUT OIL (UNII: Q9L0O73W7L)  
4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)  
SHEA BUTTER (UNII: K49155WL9Y)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
SILVER (UNII: 3M4G523W1G)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PEG-100 STEARATE (UNII: YD01N1999R)  
COCO GLUCOSIDE (UNII: ICS790225B)  
PANTHENOL (UNII: WV9CM0O67Z)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70484-105-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product04/13/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/13/2020
Labeler - Vi Medical Products Inc. (063910521)
Establishment
NameAddressID/FEIBusiness Operations
VEGE-KURL, INC021072509manufacture(70484-105)

Revised: 4/2020
Document Id: a335583c-1842-bef5-e053-2a95a90a4087
Set id: a335583c-1841-bef5-e053-2a95a90a4087
Version: 1
Effective Time: 20200413
 
Vi Medical Products Inc.