INSTANT HAND SANITIZER- instant hand sanitizer gel 
Jean Pierre 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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70483-005 INSTANT HAND SANITIZER

Active Ingredient(s)

Ethyl Alcohol 70%

Purpose

Antiseptic

Use

Helps reduce bacteria on skin. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from fire or flame.

Do not use

do not use in or near tile eyes

When using this product do not use in or near tile eyes. In case of contact, rinse eyes thoroughly with water. Do not use on open skin wounds. 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.

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

Keep out of reach of children.

Directions

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

Other information

Do not store in temperature over 118°F.

Water, Carbomer, Triethanolamine, Fragrance, Glycerine, Tocopherol (Vitamin E), Aloe Barbadensis Leaf Juice

Package Label - Principal Display Panel

1

INSTANT HAND SANITIZER 
instant hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70483-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PODOPHYLLUM RESIN (UNII: 16902YVY2B)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70483-005-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:70483-005-02240 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Jean Pierre Inc. (138328393)
Establishment
NameAddressID/FEIBusiness Operations
Jean Pierre Inc.138328393label(70483-005)
Establishment
NameAddressID/FEIBusiness Operations
ShangRao chunyu Technology CO.,LTD.541569308manufacture(70483-005)

Revised: 8/2020
Document Id: adec4da3-a1d9-476a-e053-2995a90a883d
Set id: a8a8940b-6fb1-e553-e053-2995a90a7f27
Version: 2
Effective Time: 20200828
 
Jean Pierre Inc.