NDC | 51414-107-01, 51414-107-02, 51414-107-03, 51414-107-04, 51414-107-05, 51414-107-06, 51414-107-07, 51414-107-08, 51414-107-09 |
Set ID | 5f6acc2b-7a6e-7f98-e053-2991aa0a46e7 |
Category | HUMAN OTC DRUG LABEL |
Packager | Yuyao Jessie Commodity Co.,Ltd. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- Active Ingredient
- Use
Temporarity relieves itching associated with minor skin irritations,inflammation and rashes due to :eczema,psoriasis ,insect bites,detergents,jewelry,cosmetics,soaps,seborrheic dermatitis and more
Close - WARNINGS
For External use only.
Do not use in or near the eyes,for diaper rash ;ask a doctor.ask a doctor before use if you are using any other hydrocortisone product.
stop use and ask a doctor,if .conditon worsens or if symptoms persist ofr more than 7 days. symptoms last more than 7 days or clear up and occur again within a few days.
Close - Directions
apply to affected area not more than 3 to times daily.
Children under 2 years,do not use;ask a doctor.
Close - Inactive ingredients
water,cetearyl alcohol,glycerin,ceteareth-20,isoproply myristate ,edta-2na,phenoxyethanol,tocopheryl acetate,aloe barbadensis leaf juice
Close - lebel
- INGREDIENTS AND APPEARANCE
1% HYDROCORTISONE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51414-107 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 g Inactive Ingredients Ingredient Name Strength PHENOXYETHANOL (UNII: HIE492ZZ3T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) EDETIC ACID (UNII: 9G34HU7RV0) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) CETEARETH-2 (UNII: ATB309OMWW) WATER (UNII: 059QF0KO0R) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51414-107-01 0.9 g in 1 PACKAGE; Type 0: Not a Combination Product 12/01/2016 2 NDC:51414-107-02 0.5 g in 1 PACKAGE; Type 0: Not a Combination Product 12/01/2016 3 NDC:51414-107-03 10 g in 1 PACKAGE; Type 0: Not a Combination Product 12/01/2016 4 NDC:51414-107-04 15 g in 1 PACKAGE; Type 0: Not a Combination Product 12/01/2016 5 NDC:51414-107-06 20 g in 1 PACKAGE; Type 0: Not a Combination Product 12/01/2016 6 NDC:51414-107-07 30 g in 1 PACKAGE; Type 0: Not a Combination Product 12/01/2016 7 NDC:51414-107-08 60 g in 1 PACKAGE; Type 0: Not a Combination Product 12/01/2016 8 NDC:51414-107-09 100 g in 1 PACKAGE; Type 0: Not a Combination Product 12/01/2016 9 NDC:51414-107-05 50 g in 1 PACKAGE; Type 0: Not a Combination Product 12/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/01/2015 Labeler - Yuyao Jessie Commodity Co.,Ltd. (529892305) Establishment Name Address ID/FEI Business Operations Yuyao Jessie Commodity Co.,Ltd. 529892305 manufacture(51414-107)