ANTI-ITCH- hydrocortisone 1% spray 
Car One

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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Car One LabsDrug Facts

Active ingredient                                Purpose

Hydrocortisone - 1.00%                       Anti-itch

Uses

For the temporary relief of itching associated with minor
skin irritation and rashes due to: • eczema • poison ivy, oak and
sumac • cosmetics • jewelry • soaps and detergents • insect
bites. Other uses of this product should be only under the advice
and supervision of a doctor.

Warnings
For external use only.
Flammable: Keep away from fire or flame
Avoid contact with the eyes. If condition worsens, or if symptoms
persist for more than 7 days or clear up and occur again within a
few days, stop use of this product and do not begin use of any
other hydrocortisone product unless you have consulted a doctor.
Do not use for the treatment of diaper rash. Consult a doctor.
Do not puncture or incinerate. Contents under pressure. Do not
store at temperatures above 120˚F

Keep out of reach of the children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

• 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: do not use, consult a doctor


Inactive ingredients

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

image description

ANTI-ITCH 
hydrocortisone 1% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-366
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:41520-366-0385 g in 1 CAN; Type 0: Not a Combination Product02/19/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/19/2013
Labeler - Car One (809183973)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(41520-366) , label(41520-366)

Revised: 6/2018
Document Id: 582e0ae8-355b-4d20-928c-8f2952b030f5
Set id: ba27d27b-e4c7-4923-8a83-3e759124f35a
Version: 1
Effective Time: 20180619
 
Car One