1% HYDROCORTISONE- hydrocortisone cream

1% Hydrocortisone by

Drug Labeling and Warnings

1% Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Yuyao Jessie Commodity Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

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

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.

keep out of reach of children

if ingested,contact a Poison Control Center right away.

Directions

apply to affected area not more than 3 to times daily.

Children under 2 years,do not use;ask a doctor.

Inactive ingredients

water,cetearyl alcohol,glycerin,ceteareth-20,isoproply myristate ,edta-2na,phenoxyethanol,tocopheryl acetate,aloe barbadensis leaf juice

lebel

INGREDIENTS AND APPEARANCE

1% HYDROCORTISONE 
hydrocortisone cream

Product 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)