Label: POST-TREATMENT REPAIR CREAM- hydrocortisone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70484-007-01 - Packager: Vi Medical Products Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 28, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- USES
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
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
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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
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
POST-TREATMENT REPAIR CREAM
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70484-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:70484-007-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/04/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/04/2020 Labeler - Vi Medical Products Inc. (063910521) Establishment Name Address ID/FEI Business Operations VEGE-KURL, INC 021072509 manufacture(70484-007)
