RENEW - Gel Hand Sanitizer - Lavender

RENEW Gel Hand Sanitizer by

Drug Labeling and Warnings

RENEW Gel Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by CORECHEM Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RENEW GEL HAND SANITIZER- ethyl alcohol 70% v/v gel 
CORECHEM 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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RENEW - Gel Hand Sanitizer - Lavender

ACTIVE INGREDIENT

Active Ingredient

Ethyl alcohol 70% v/v

PURPOSE

Purpose

Antiseptic

USE

Use
Hand sanitizer to decrease bacteria on the skin that could cause disease. For use when soap and water are not available.

WARNINGS

Warnings
For external use only: hands
Flammable. Keep away from heat or flame.

DO NOT USE

Do not use
on children less than 2 months of age on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth.
In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

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

Other information
Do not store above 115°F May discolor some fabrics.
May damage wood finishes or plastics.

INACTIVE INGREDIENTS

Inactive ingredients
Fragrance, glycerin, isopropyl alcohol, PEG-6 (and) AMP-acrylates/vinyl
isodecanoate crosspolymer, purified water

HAND SANITIZER GEL, LAVENDER FRAGRANCE, 1 GALLON (3.785 L) - PACKAGE LABEL

Green Diversified Systems - Hand Sanitizer Gel - Lavender - 128oz (3.875L) - 20201026 FDA# 75029-252-30

RENEW GEL HAND SANITIZER 
ethyl alcohol 70% v/v gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75029-252
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)
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75029-252-30	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/27/2020	11/30/2022

Labeler - CORECHEM Inc. (070056445)

Revised: 11/2022

Document Id: ee4d0ea3-e7d0-5289-e053-2995a90af095

34390-5

Set id: b2a6527b-ec05-74e7-e053-2995a90a2be9

Version: 5

Effective Time: 20221125