R&Co ANTISEPTIC HAND SANITIZER

R and Co PALM READER ANTISEPTIC HAND SANITIZER by

Drug Labeling and Warnings

R and Co PALM READER ANTISEPTIC HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by 220 Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

R AND CO PALM READER ANTISEPTIC HAND SANITIZER- ethyl alcohol gel 
220 Laboratories 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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R&Co ANTISEPTIC HAND SANITIZER

Drug Facts

Active ingredient

Ethyl alcohol 69% v/v

Purpose

Antiseptic

Uses

hand sanitizer to decrease bacteria on the skin

recommended for repeated use

for use when soap and water are not available

Warnings

Flammable, keep away from fire/flame

For external use only

Do not use

in children less than 2 months of age

on open skin wounds

When using this product do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

irritation and redness develop

condition persists for more than 72 hours

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

Directions

wet hands thoroughly with product and allow to dry without wiping

supervise children under 6 years of age when using this product to avoid swallowing

Other information

store between 15-30°C (59-86°F)

avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

aloe vera (Aloe barbadensis) leaf juice, aminomethyl propanol, carbomer, glycerin, propanediol, propylene glycol, tocopheryl acetate, water

Questions?

1-855-726-3265

You may also report serious side effects to this phone number.

Mon-Fri 9:00 AM - 5:00 PM

PALM READER

Distributed by: Rogue & Co. LLC. Miami, FL 33137

57367-201-30

Packaging

R AND CO PALM READER ANTISEPTIC HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57367-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	69 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57367-201-30	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2020	07/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/04/2020	07/01/2022

Labeler - 220 Laboratories Inc. (783247950)

Establishment
Name	Address	ID/FEI	Business Operations
220 Laboratories Inc.		783247950	manufacture(57367-201)

Revised: 3/2022

Document Id: a72b5dd1-1986-4398-8abe-971c4facde95

34390-5

Set id: 30278cc0-e79e-4ab7-bcb0-be7043bb8f2c

Version: 2

Effective Time: 20220302