OTC Medication Information: Gel Antibacterial

GEL ANTIBACTERIAL- alcohol gel
QUIBI S A EN REESTRUCTURACION

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)

Alcohol 65% v/v Purpose: Antiseptic

Purpose

Aseptic, Hand Sanitizer

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

– in children under 2 months of age

– in open skin wound

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

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions

Directions

– Place enough product on hands to cover ll surfaces. Rub hands together until dry.

– Supervise children under 6 years of age when using this product to avoid ingestion swallowing.

Other Information

– Store between 15-30C (59-86F)

– Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Glycerin USP, Triethanolamine USP, Purified Water USP, Carbopol

Package Label. Principal Display Panel.

Gel Antibacterial Label
(click image for full-size original)
Gel Antibacterial Label
(click image for full-size original)

GEL ANTIBACTERIAL
gel antibacterial gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:81815-121
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 65 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
GLYCERIN
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:81815-121-44 60 mL in 1 BOTTLE, PLASTIC None
2 NDC:81815-121-51 200000 mL in 1 BOTTLE, PLASTIC None
3 NDC:81815-121-48 3800 mL in 1 BOTTLE, PLASTIC None
4 NDC:81815-121-43 1000 mL in 1 BOTTLE, PLASTIC None
5 NDC:81815-121-47 500 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 10/14/2021
Labeler — QUIBI S A EN REESTRUCTURACION (881118475)
Establishment
Name Address ID/FEI Operations
QUIBI S A EN REESTRUCTURACION 881118475 manufacture (81815-121), pack (81815-121), label (81815-121), analysis (81815-121)

Revised: 07/2021 QUIBI S A EN REESTRUCTURACION

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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