PLAN 36.5 HAND SANITIZER- alcohol gel

PLAN 36.5 HAND SANITIZER by

Drug Labeling and Warnings

PLAN 36.5 HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by 2bko, DongbangCosmetics Co., ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient: ALCOHOL 70% w/w

INACTIVE INGREDIENT

Inactive ingredients:

Water, Carbomer, Tetrahydroxypropyl Ethylenediamine, Tocopheryl Acetate, Lavandula Angustifolia (Lavender) Oil, Fragaria Ananassa (Strawberry) Fruit Extract, Sophora Angustifolia Root Extract, Morus Alba Bark Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Citrus Paradisi (Grapefruit) Fruit Extract, Camellia Sinensis Leaf Extract, Aloe Barbadensis Extract, Salvia Officinalis (Sage) Extract

PURPOSE

Purpose: ANTISEPTIC

WARNINGS

Warnings:

For external use only. Flammable. Keep away from heat or flame
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Do not use
in children less than 2 months of age
on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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.

Uses

Uses:

Hand sanitizer to help reduce bacteria that potentially can cause disease.

Directions

Directions:

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Other information:

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PLAN 36.5 HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73264-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
EDETOL (UNII: Q4R969U9FR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LAVENDER OIL (UNII: ZBP1YXW0H8)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
MORUS ALBA BARK (UNII: 7O71A48NDP)
GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K)
GRAPEFRUIT (UNII: O82C39RR8C)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73264-012-01	100 mL in 1 CONTAINER; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/01/2020

Labeler - 2bko (695063277)

Registrant - 2bko (695063277)

Establishment
Name	Address	ID/FEI	Business Operations
DongbangCosmetics Co., ltd.		694452564	manufacture(73264-012)