hand gel by Jean Pierre Inc. / Guangzhou meizi biotechnology co. LTD HAND GEL gel

hand gel by

Drug Labeling and Warnings

hand gel by is a Otc medication manufactured, distributed, or labeled by Jean Pierre Inc., Guangzhou meizi biotechnology co. LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

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

INGREDIENTS AND APPEARANCE

HAND GEL 
hand gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70483-018
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70483-018-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 70483-018-02	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC: 70483-018-03	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - Jean Pierre Inc. (138328393)

Establishment
Name	Address	ID/FEI	Business Operations
Jean Pierre Inc.		138328393	label(70483-018)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou meizi biotechnology co. LTD		403308233	manufacture(70483-018)