ANTI-ITCH SCHERER LABS- hydrocortisone 1.00% spray 
Kmart Corporation

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 Facts

Active ingredient                         Purpose


Hydrocortisone 1.0%....................Anti-itch

Uses

Temporarily relieves itching associated with minor skin irritation, inflammation and rashes due to:
• eczema • poison ivy, oak and sumac • cosmetics • psoriasis • soaps and detergents • jewelry • insect bites • seborrheic dermatitis

Warnings
For external use only.

Flammable: Do not use while smoking or near heat or flame

Do not use • in or near the eyes • for external genital, vaginal or anal itching • for diaper rash; ask a doctor


When using this product • keep out of eyes. Rinse with water to remove. • use only as directed. • Do not puncture or incinerate.
Contents under pressure. Do not store at temperatures above 120ºF.

​Ask a doctor before use if​ you are using any other hydrocortisone product


Stop use and ask doctor if •condition worsens or does not improve within 7 days • symptoms persist for more than 7 days or clear up and occur again with in a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions • shake well • 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: ask a doctor • to apply to face, spray into palm of hand and gently apply

Inactive ingredients

Citric Acid, Disodium EDTA, Glycerin, Poloxamer 188, Polysorbate 20, SD Alcohol 40-B, Water.

image descriptionimage description

ANTI-ITCH  SCHERER LABS
hydrocortisone 1.00% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-219
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) Hydrocortisone1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Glycerin (UNII: PDC6A3C0OX)  
Poloxamer 188 (UNII: LQA7B6G8JG)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
ALCOHOL (UNII: 3K9958V90M)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49738-219-0385 g in 1 CAN; Type 0: Not a Combination Product04/15/201303/08/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/15/201303/08/2018
Labeler - Kmart Corporation (008965873)
Registrant - Product Quest (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest927768135manufacture(49738-219) , label(49738-219)

Revised: 3/2018
Document Id: 8e83ca60-f67d-4c64-8633-512609daa432
Set id: 1367ddbb-8c40-46ed-b54a-a129b8a78fbd
Version: 2
Effective Time: 20180329
 
Kmart Corporation