Hand Gel: Package Insert and Label Information

HAND GEL- alcohol 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.

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 30ML
(click image for full-size original)
70483-018-02 30ML
(click image for full-size original)
70483-018-03 30ML
(click image for full-size original)

HAND GEL
hand gel gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70483-018
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
PROPYLENE GLYCOL
WATER
TROLAMINE
FRAGRANCE CLEAN ORC0600327
FD&C RED NO. 40
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
ALOE VERA LEAF
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70483-018-01 30 mL in 1 BOTTLE None
2 NDC:70483-018-02 30 mL in 1 BOTTLE None
3 NDC:70483-018-03 30 mL in 1 BOTTLE None
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 Operations
Jean Pierre Inc. 138328393 label (70483-018)
Establishment
Name Address ID/FEI Operations
Guangzhou meizi biotechnology co. LTD 403308233 manufacture (70483-018)

Revised: 10/2020 Jean Pierre Inc.

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