R and Co PALM READER ANTISEPTIC HAND SANITIZER: Package Insert and Label Information

R AND CO PALM READER ANTISEPTIC HAND SANITIZER- 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.

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

untitled
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 69 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
AMINOMETHYLPROPANOL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
GLYCERIN
PROPANEDIOL
PROPYLENE GLYCOL
.ALPHA.-TOCOPHEROL ACETATE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57367-201-30 177 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 06/04/2020
Labeler — 220 Laboratories Inc. (783247950)
Establishment
Name Address ID/FEI Operations
220 Laboratories Inc. 783247950 manufacture (57367-201)

Revised: 06/2020 220 Laboratories Inc.

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