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

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

Purpose: ANTISEPTIC

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

Image of bottleImage of bottle

PLAN 36.5 HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81539-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL350 mL  in 500 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81539-030-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/01/202110/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/01/202110/01/2021
Labeler - BASCARE INC (695098318)
Registrant - BASCARE INC (695098318)
Establishment
NameAddressID/FEIBusiness Operations
DongbangCosmetics Co., ltd.694452564manufacture(81539-030)

Revised: 11/2021
 
BASCARE INC