HYDROCORTISONE- hydrocortisone continuous spray aerosol, spray 
Premier Brands of America, Inc.

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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Cutter Poison Ivy Itch Relief

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

Warnings

For external use only.

Flammable:

Keep away from heat, sparks and open flame. Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120 ºF. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

Do not use

  • for external genital, vaginal or anal itching
  • with other hydrocortisone product unless directed by a doctor
  • in or near the eyes
  • for diaper rash

When using this product

  • avoid contact with the eyes
  • if product gets into the eye, flush with water for 15 minutes

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days and do not begin use of any other hydrocortisone product unless you have consulted a doctor

Keep out of the reach of children.

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

Directions

Inactive ingredients

aloe barbadensis leaf juice, avena sativa (oat) kernel extract, citric acid, disodium EDTA, ethoxydiglycol, glycerin, maltodextrin, menthyl lactate, methyl gluceth-20, PEG-8, SD alcohol 40-B, sodium citrate, water

Questions ?

Call 1-866-964-0939

Principal Display Panel

Cutter
Poison Ivy Itch Relief

For Poison Ivy, Oak, & Sumac

Maximum Strength

Relieves Itching

Calms irritated skin

No touch, no mess

HYDROCORTISONE 1% / ANTI-ITCH

NET WT 4.0 0Z (113 g)

Artwork

HYDROCORTISONE 
hydrocortisone continuous spray aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-250
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1.13 g  in 113 g
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
OAT (UNII: Z6J799EAJK)  
WATER (UNII: 059QF0KO0R)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
ALCOHOL (UNII: 3K9958V90M)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56104-250-00113 g in 1 CAN; Type 0: Not a Combination Product12/20/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/20/2021
Labeler - Premier Brands of America, Inc. (117557458)

Revised: 1/2023
Document Id: f32cc999-16e8-0bcb-e053-2a95a90a05b8
Set id: d344f68b-9b62-3029-e053-2995a90a1665
Version: 2
Effective Time: 20230126
 
Premier Brands of America, Inc.