PAUME MOISTURIZING ANTIBACTERIAL HAND GEL- alcohol gel

Paume Moisturizing Antibacterial Hand Gel by

Drug Labeling and Warnings

Paume Moisturizing Antibacterial Hand Gel by is a Otc medication manufactured, distributed, or labeled by Paume Inc, Prime Potions Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethyl alcohol 69% v/v

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Put enough product in your palm to cover hands and rub together thoroughly until dry. Children under the age of 5 should be supervised by an adult when using this product.

WARNINGS

For external use only. Flammable. Keep away from heat or flame.

Do not use -in children less than 2 years of age -on open skin wounds.

When using this product - keep out of eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if -irritation and redness develop.

INACTIVE INGREDIENT

Purified water, Witch Hazel Extract, Safflower oleosomes in glycerin and aqua, Hydroxypropyl Methylcellulose, Cedarwood Essential Oil, Lavender Essential Oil, Rosemary Essential Oil, Lemon Essential Oil, Orange Essential Oil, Aloe Vera Powder 200X (certified organic).

INDICATIONS & USAGE

To help reduce bacteria on the skin.

PURPOSE

Antimicrobial

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAUME MOISTURIZING ANTIBACTERIAL HAND GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80328-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	69 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ORANGE OIL (UNII: AKN3KSD11B)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
LAVENDER OIL (UNII: ZBP1YXW0H8)
CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)
ROSEMARY OIL (UNII: 8LGU7VM393)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
WITCH HAZEL (UNII: 101I4J0U34)
LEMON OIL (UNII: I9GRO824LL)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)

Product Characteristics
Color		Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80328-123-01	90 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/22/2020
2	NDC: 80328-123-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/22/2020
3	NDC: 80328-123-03	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	12/22/2020

Labeler - Paume Inc (204193739)

Registrant - Paume Inc (204193739)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Potions Inc.		208527351	manufacture(80328-123) , label(80328-123) , pack(80328-123)