PFA STRONGHOLD SANITIZING HANDLOTION SHEA BUTTER- 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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80969-007-01 PFA STRONGHOLD SANITIZING HAND LOTION_SHEA BUTTER

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, Centella Asiatica Extract, Cocos Nucifera (Coconut) Oil, Polysorbate 80, Fragrance, Benzyl Salicylate, Coumarin, Limonene, Linalool

Package Label

80969-007-01

PFA STRONGHOLD SANITIZING HANDLOTION SHEA BUTTER 
alcohol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80969-007
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)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
COUMARIN (UNII: A4VZ22K1WT)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
SHEA BUTTER (UNII: K49155WL9Y)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
COCONUT OIL (UNII: Q9L0O73W7L)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)  
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80969-007-012 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(80969-007)

Revised: 1/2023
Document Id: f321f8f3-8625-147a-e053-2995a90a9b59
Set id: d1fdd2c5-2360-6084-e053-2995a90aa2f9
Version: 2
Effective Time: 20230125
 
STRONGHOLD TRADING LLC