THE SAEM CLEAN EVERYDAY HAND SANITIZER GEL- alcohol gel

the SAEM Clean Everyday Hand Sanitizer gel by

Drug Labeling and Warnings

the SAEM Clean Everyday Hand Sanitizer gel by is a Otc medication manufactured, distributed, or labeled by The Saem International Co., Ltd., Rainbow Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl alcohol 70%

Purpose

Antimicrobial

Use

• Hand sanitizer to help reduce bacteria on the skin

Warnings

Flammable. Keep away from fire or flame.

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

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

Directions

• Put nough produt in your palm to cover hands and rub hands together briskly until dry.
• Children under 6 years of age should be supervised when using this product

Other information

• Store below 110°F (43°C)
• May discolor certain fabrics or surfaces

Inactive ingredients

Water, Dipropylene Glycol, Carbomer, Glycerin, Triethanolamine, PEG-60 Hydrogenated Caster Oil, Panthenol, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Extract, Diethanolamine, Citrus Paradisi (Grapefruit) Peel Oil, Sodium Hyaluronate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THE SAEM CLEAN EVERYDAY HAND SANITIZER GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70341-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
PANTHENOL (UNII: WV9CM0O67Z)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIETHANOLAMINE (UNII: AZE05TDV2V)
GRAPEFRUIT OIL (UNII: YR377U58W9)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70341-001-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2020
2	NDC: 70341-001-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2020
3	NDC: 70341-001-03	100 mL in 1 TUBE; Type 0: Not a Combination Product	04/13/2020
4	NDC: 70341-001-04	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/13/2020
5	NDC: 70341-001-05	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2020
6	NDC: 70341-001-06	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/13/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/13/2020

Labeler - The Saem International Co., Ltd. (689402402)

Registrant - The Saem International Co., Ltd. (689402402)

Establishment
Name	Address	ID/FEI	Business Operations
Rainbow Co Ltd		690423720	manufacture(70341-001)