Pacomeri Advanced Hand Sanitizer: Package Insert and Label Information

PACOMERI ADVANCED HAND SANITIZER- alcohol gel
Newfeel

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

Active ingredients: Ethyl alcohol 75% v/v

INACTIVE INGREDIENT

Inactive ingredients:

PURIFIED WATER, CARBOMER, BUTYLENE GLYCOL, GLYCERIN, SODIUM HYALURONATE, TRIETHANOLAMINE, FRAGRANCE

PURPOSE

Purpose: Antiseptic

WARNINGS

Warnings:
For external use only : hands
Flammable, keep away from fire or flame.
When using this product ■ keep out of eyes. In case of contact with eyes, flush thoroughly with water. ■ avoid contact with broken skin. ■ do not inhale or ingest
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.

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.

Uses

Uses:
■ for handwashing to decrease the bacteria on the skin
■ recommended for repeated use

Directions

Directions:

■ wet hands thoroughly with product and allow to dry without wiping

■ for children under 6, use only under adult supervision

■ not recommended for infants

Other information

Other information


■ do not store above 105℉

■ may discolor some fabrics

■ harmful to wood finishes and plastics

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottle
(click image for full-size original)

PACOMERI ADVANCED HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73713-060
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 375 mL in 500 mL
Inactive Ingredients
Ingredient Name Strength
Water
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
BUTYLENE GLYCOL
Glycerin
HYALURONATE SODIUM
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73713-060-01 500 mL in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 04/01/2020
Labeler — Newfeel (690062383)
Registrant — Newfeel (690062383)
Establishment
Name Address ID/FEI Operations
Newfeel 690062383 manufacture (73713-060)

Revised: 05/2020 Newfeel

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