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Hydrocortisone by American Spraytech, LLC

Dosage form: liquid
Ingredients: HYDROCORTISONE 10mg in 1g
Labeler: American Spraytech, LLC
NDC Code: 68754-206

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.

Hydrocortisone

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch 

Uses

For the temporary relief of itching associatd with minor skin irritations, inflammation, and rashes due to: • eczema • insect bites • poison ivy • poison oak • poison sumac soaps • jewelry • detergents • cosmetics • seborrheic dermatitis • psonasis • other uses of this product should be only under the advice and supervision of doctor 

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° F. Interntional 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 consulted 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.

Keep out of reach of children.

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

Directions
  • twist cap left to unlock actuator
  • adults and children 2 years of age and older: spray affected area not more than 3 to 4 times daily
  • children under 2 years of age: do not use, consult a doctor 
  • to apply to face, spray into palm of hand and gently apply

Other information
  • store between 20° and 25°C (68° and 77°F)

Inactive ingredients

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

Questions?

Call 1-888-287-1915

Package Labeling:

HYDROCORTISONE 
hydrocortisone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68754-206
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
OAT 
CITRIC ACID MONOHYDRATE 
EDETATE DISODIUM ANHYDROUS 
DIETHYLENE GLYCOL MONOETHYL ETHER 
GLYCERIN 
MALTODEXTRIN 
MENTHYL LACTATE, (-)- 
METHYL GLUCETH-20 
POLYETHYLENE GLYCOL 400 
SODIUM CITRATE, UNSPECIFIED FORM 
WATER 
Packaging
#Item CodePackage Description
1NDC:68754-206-00113 g in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/26/2017
Labeler - American Spraytech, LLC (137135237)

Revised: 12/2017
 
American Spraytech, LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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