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

Hydrocortisone 1% Purpose 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.

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

For external use only. Avoid contact with eyes. 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. Do not use this or any other hydrocortisone product unless you have consulted a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Adults and children 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, Sderocarya Birrea Seed Oil, Sodium Polyacrylate, Tocopherol Acetate

Store at 20C (66 - 77F)

VI DERM Beauty

Post-Treament Repair Cream

Anti-Itch Cream Hydrocortisone 1%

1 FL OZ / 30mL

Post-Treatment Repair Cream

POST-TREATMENT REPAIR CREAM 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70484-007
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
GINGER (UNII: C5529G5JPQ)  
SHEA BUTTER (UNII: K49155WL9Y)  
COCO GLUCOSIDE (UNII: ICS790225B)  
COCONUT ALCOHOL (UNII: 13F4MW8Y9K)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)  
SILVER (UNII: 3M4G523W1G)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
PANTHENOL (UNII: WV9CM0O67Z)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
WATER (UNII: 059QF0KO0R)  
CURDLAN (UNII: 6930DL209R)  
LEVOMENOL (UNII: 24WE03BX2T)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70484-007-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/04/2020
Labeler - Vi Medical Products Inc. (063910521)
Establishment
NameAddressID/FEIBusiness Operations
VEGE-KURL, INC021072509manufacture(70484-007)

Revised: 7/2020
Document Id: ab8885a9-0779-28ff-e053-2995a90a2e12
Set id: ab8885a9-0778-28ff-e053-2995a90a2e12
Version: 1
Effective Time: 20200728
 
Vi Medical Products Inc.