PFA STRONGHOLD SANITIZING HANDLOTION MINT- alcohol lotion 
STRONGHOLD TRADING LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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80969-006-01 PFA STRONGHOLD SANITIZING HAND LOTION_MINT

Active ingredient

Alcohol 62%

Purpose

Sanitizer

Use

Hand sanitizing to help reduce bacteria on the skin.

Warnings

For external use only.

Flammable. Keep away from fire or flame.

When using this product

avoid contact with the eyes.

In case of contact, flush eyes thoroughly with water.

Stop use and ask a doctor

if irritation and redness develops and persists.

Keep out of reach of children.

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

Directions

Other information

Inactive ingredients

Water, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, PEG-60 Hydrogenated Castor Oil, Glyceryl Stearate, Glycerin, PEG-100 Stearate, Ammonium Polyacryloyldimethyl Taurate, Caprylic/Capric Triglyceride, Mentha Rotundifolia Leaf Extract, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Melissa Officinalis Leaf Extract, Cymbopogon Schoenanthus Extract, Centella Asiatica Extract, Polysorbate 80, Mentha Piperita (Peppermint) Oil, Limonene

Package Label

80969-006-01

PFA STRONGHOLD SANITIZING HANDLOTION MINT 
alcohol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80969-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYOXYL 60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
MENTHA X ROTUNDIFOLIA LEAF (UNII: K59TXG2L3U)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
SHEA BUTTER (UNII: K49155WL9Y)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
CYMBOPOGON SCHOENANTHUS TOP (UNII: 9SJI1LW39W)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)  
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80969-006-012 mL in 1 POUCH; Type 0: Not a Combination Product11/26/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/26/2021
Labeler - STRONGHOLD TRADING LLC (117694134)
Registrant - S-ONE PHARMACEUTICAL INC (694626932)
Establishment
NameAddressID/FEIBusiness Operations
S-ONE PHARMACEUTICAL INC694626932manufacture(80969-006)

Revised: 1/2023
Document Id: f321a5ba-6e3d-cfbb-e053-2995a90a26e0
Set id: d1abb02f-5ad2-5d41-e053-2a95a90aa0a7
Version: 2
Effective Time: 20230125
 
STRONGHOLD TRADING LLC