PLAN 36.5 HAND SANITIZER by BASCARE INC / DongbangCosmetics Co., ltd.

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 BASCARE INC, DongbangCosmetics Co., ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PLAN 36.5 HAND SANITIZER- alcohol gel 
BASCARE INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

Active ingredient: ALCOHOL 70% w/w

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

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

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

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

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

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PLAN 36.5 HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81539-020
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: 81539-020-01	100 mL in 1 CONTAINER; Type 0: Not a Combination Product	02/01/2021	10/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/01/2021	10/01/2021

Labeler - BASCARE INC (695098318)

Registrant - BASCARE INC (695098318)

Establishment
Name	Address	ID/FEI	Business Operations
DongbangCosmetics Co., ltd.		694452564	manufacture(81539-020)

Revised: 11/2021

Document Id: 2b9a51fe-0717-4abb-8dab-cc59408284a6

34390-5

Set id: facc7a4e-c375-4052-b398-917d06de3719

Version: 2

Effective Time: 20211105