75% ALCOHOL HAND SANITIZER- 75% alcohol hand sanitizer gel 
PHOENYX DISTRIBUTING, LLC

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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75% ALCOHOL HAND SANITIZER

Active Ingredient(s)

Alcohol 75% v/v.

Purpose

Antiseptic

Use

Helps reduce bacea at pontentially can caus dsease

Helps prevent Cross contamination on contact

Recommended for repeated use

Warnings

For external use only

Flammable, Keep away from fire or flame

Do not use near eyesIn case of eye contact flush with water for 15 minutes

If imitation persists stop use of product and get medical attention

Keep out of reach of childrenIn case of accidental ingestion seek medical attention orcontact a poison contro center immediately

Do not use

When using this product

Do not use in or near the eyes. In case of contact with eyes flush thoroughly with water

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Keep out of reach of children. case of accidental ingestion seek medical attention orcontact a poison contro center immediately

Directions

Wet hands thoroughly with product and rub completely Covering hands
Allow to dry without wiping
children under the age of 6 should use with adult supervision
Not recommended for infants

Other information

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Inactive ingredients

Water(Aqua), PEG-40 Hydrogenated Castor Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer,
Fragrance (Parfum) Aminomethyl Propanol

Package Label - Principal Display Panel

321

75% ALCOHOL HAND SANITIZER 
75% alcohol hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79316-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
WATER (UNII: 059QF0KO0R)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79316-008-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:79316-008-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - PHOENYX DISTRIBUTING, LLC (128029831)
Establishment
NameAddressID/FEIBusiness Operations
PHOENYX DISTRIBUTING, LLC128029831label(79316-008)
Establishment
NameAddressID/FEIBusiness Operations
Fortress Expert Co., Ltd543358697manufacture(79316-008)

Revised: 6/2020
Document Id: a91d28d9-9e1d-0f5b-e053-2a95a90a9892
Set id: a91cf949-9e53-0f61-e053-2a95a90a1322
Version: 1
Effective Time: 20200627
 
PHOENYX DISTRIBUTING, LLC