AMORAY PREMIUM INSTANT HAND SANITIZER- 3k9958v90m liquid 
SUDESAN TEMIZLIK URUNLERI VE AMBALAJ SANAYI TICARET ANONIM SIRKETI

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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Instant Hand Sanitizer

Ethyl Alcohol 62% ......................... Antiseptic

Keep out of reach of children. Children must be supervised in use of this product

Back Label

Inactive Ingredients water, triethanolamine, glycerin, carbomer, PEG-40 hydrogenated castor oil, propylene gylcol, fragrance, tocopheryl acetate

Inactive Ingredients

For External Use Only:

Flammable. Keep away from fire or flame.

Do not apply around eyes. Do not use in ears or mouth

When using this product, avoid contact with eyes. In cases of contact flush eyes with water

Stop Use and ask doctor if redness or irritation develop and persist for more than 72 hours.

Keep out of reach of children.Children must be supervised in use of this product.

Warnings

Pump as needed into your palms and thouroughly spreand on both hands - rub into skin until dry.

Use Hand Sanitizer to decrease bacteria on the skin. - when water, soap & towel are not available. - Reccomended for repeated use

Uses

hand sanitizer to help decrease bacteria on the skin. - when water, soap & towel are not available. - reccomended for repeated use.

Purpose

Principal Package Label

AMORAY PREMIUM INSTANT HAND SANITIZER 
3k9958v90m liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73580-4220
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL250 mL  in 250 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73580-4220-5250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/07/2020
Labeler - SUDESAN TEMIZLIK URUNLERI VE AMBALAJ SANAYI TICARET ANONIM SIRKETI (365908917)
Registrant - SUDESAN TEMIZLIK URUNLERI VE AMBALAJ SANAYI TICARET ANONIM SIRKETI (365908917)
Establishment
NameAddressID/FEIBusiness Operations
SUDESAN TEMIZLIK URUNLERI VE AMBALAJ SANAYI TICARET ANONIM SIRKETI365908917manufacture(73580-4220)

Revised: 1/2020
Document Id: 9d4db60e-ed97-79cc-e053-2995a90aa8b0
Set id: 9d4db60e-ed96-79cc-e053-2995a90aa8b0
Version: 1
Effective Time: 20200129
 
SUDESAN TEMIZLIK URUNLERI VE AMBALAJ SANAYI TICARET ANONIM SIRKETI