HAND GEL- hand gel 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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70483-018
hand gel

Active Ingredient(s)

Ethyl Alcohol 70%

Purpose

Antiseptic

Use

Hand sanitizer to help decrease bacteria on the skin when water, soap & towel are not available. Recommended for repeated use

Warnings

Do not use

Do not apply around eyes. Do not use in ears or mouth.

When using this product, avoid contact with eyes. In case of contact, flush eyes with water.

Stop use or ask for a doctor if redness or irritation develops and persists for more than 72 hours.

Keep out of reach of children. Children must be supervised in use of this product.

Stop use or ask for a doctor if redness or irritation develops and persists for more than 72 hours.

Keep out of reach of children. Children must be supervised in use of this product.

Directions

Squeeze as needed into your palms and thoroughly spread on bottom hands. Rub into skin until dry.

Other information

Do not store in temperature over 118°F.

Inactive ingredients

Water, Propylene Glycol, Glycerin, Carbomer, Aloe Barbadensis Leaf Juice, Triethanolamine, Fragrance. May Contain: FD & C Red No. 4, FD & C Blue No. 1, FD & C Yellow No 5.

Package Label - Principal Display Panel

70483-018-01 30ML70483-018-02 30ML70483-018-03 30ML

HAND GEL 
hand gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70483-018
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
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70483-018-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:70483-018-0230 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:70483-018-0330 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(70483-018)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou meizi biotechnology co. LTD403308233manufacture(70483-018)

Revised: 10/2020
Document Id: b1c5f589-3a09-4c18-e053-2a95a90ae1cc
Set id: b1c5fc25-2cf1-6699-e053-2a95a90a9dea
Version: 1
Effective Time: 20201016
 
Jean Pierre Inc.