1% HYDROCORTISONE- hydrocortisone cream
Yuyao Jessie Commodity Co.,Ltd.

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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Insect Bite Relief Spray 51414-107

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

1% HYDROCORTISONE
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51414-107
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	12/01/2015

Labeler - Yuyao Jessie Commodity Co.,Ltd. (529892305)

Name	Address	ID/FEI	Business Operations
Establishment
Yuyao Jessie Commodity Co.,Ltd.		529892305	manufacture(51414-107)

Revised: 12/2022

Document Id: f0033086-4ab2-b3e3-e053-2995a90ad171

Set id: 5f6acc2b-7a6e-7f98-e053-2991aa0a46e7

Version: 6

Effective Time: 20221217

Yuyao Jessie Commodity Co.,Ltd.