SATSUMA HAND SANITIZER- alcohol gel

Satsuma Hand Sanitizer by

Drug Labeling and Warnings

Satsuma Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by REACTION RETAIL LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient:

Ethyl Alcohol 75%

Antiseptic

Uses:

Hand sanitizer to help decrease bacteria on the skin.

Warnings:

For external use only.

Flammable. Keep away from fire or flame.

Stop use and ask doctor if

irritation or rash appears and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a doctor right away.

Directions:

Squirt as needed into your palms and thoroughly spread on both hands. Rub into skin until dry.

Other Information:

Store below 118°F

Inactive Ingredients:

Aqua (Water), Glycerin, Propylene Glycol, Aloe Barbadensis Leaf Juice, Parfum (Fragrance), Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Benzophenone-3, Triethanolamine, Citric Acid, Potassium Sorbate, Sodium Benzoate, Sucrose, Zea Mays (Corn) Starch, Hydroxypropyl Methylcellulose, Polyvinyl Alcohol, Limonene, Citral, Citronello, Linalool, CI 77267 (D&C Black No.3), CI 19140(FD&C Yellow No.5), CI42090 (FD&C Blue No.1).

Package Labeling:

INGREDIENTS AND APPEARANCE

SATSUMA HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80026-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
OXYBENZONE (UNII: 95OOS7VE0Y)
TROLAMINE (UNII: 9O3K93S3TK)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
LIMONENE OXIDE, (+)- (UNII: 278IM94GXB)
CITRAL (UNII: T7EU0O9VPP)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
D&C BLACK NO. 2 (UNII: 4XYU5U00C4)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80026-012-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/20/2020

Labeler - REACTION RETAIL LLC (968085212)