PFA STRONGHOLD SANITIZING HANDLOTION ROSE- alcohol lotion

PFA STRONGHOLD SANITIZING HANDLOTION ROSE by

Drug Labeling and Warnings

PFA STRONGHOLD SANITIZING HANDLOTION ROSE by is a Otc medication manufactured, distributed, or labeled by STRONGHOLD TRADING LLC, S-ONE PHARMACEUTICAL INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• Put enough product in the palm to cover hands & rub together briskly the liquid is dry
• Children under 6 should be supervised when using Sanitizers.

Other information

• Store below 77°F (25°C)
• May discolor certain fabrics or surfaces.

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, Rosa Damascena Flower Water, Centella Asiatica Extract, Polysorbate 80, Fragrance, Citronellol, Eugenol, Geraniol, Hexyl Cinnamal

Package Label

INGREDIENTS AND APPEARANCE

PFA STRONGHOLD SANITIZING HANDLOTION ROSE 
alcohol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80969-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
GERANIOL (UNII: L837108USY)
EUGENOL (UNII: 3T8H1794QW)
SHEA BUTTER (UNII: K49155WL9Y)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80969-008-01	2 mL in 1 POUCH; Type 0: Not a Combination Product	01/26/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/26/2023

Labeler - STRONGHOLD TRADING LLC (117694134)

Registrant - S-ONE PHARMACEUTICAL INC (694626932)

Establishment
Name	Address	ID/FEI	Business Operations
S-ONE PHARMACEUTICAL INC		694626932	manufacture(80969-008)