biom Sanitizing Alcohol Wipes - Bergamot Bloom

Manufacturer
Biom Innovations Inc
Effective date
2024-12-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:48:32

Label at a glance#

Productbiom Sanitizing Alcohol Wipes - Bergamot Bloom
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Wipe hands thoroughly. Discard after use.

Storage and handling

Store below 104° F (40° C). Each wipe is 15 x 20 cm. May discolor certain fabrics. Do not use as a baby wipe, on the face, or in the genital area.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (65%, volume/volume (w/w)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 65% w/w. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Reducing bacteria on skin.

Directions

INDICATIONS & USAGE SECTION

Wipe hands thoroughly. Discard after use.

Warnings

WARNINGS SECTION

Flammable. Keep away from Fire and Flame. External Use Only. Do not use in eyes. If contact occurs, flush thoroughly with water. Stop use and ask doctor if redness or irritation develops and continues for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact the poison control center immediately.

OTC - STOP USE SECTION

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

Other information

STORAGE AND HANDLING SECTION

Store below 104° F (40° C).
Each wipe is 15 x 20 cm.
May discolor certain fabrics.
Do not use as a baby wipe, on
the face, or in the genital area.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Citrus Bergamia Peel Oil (Bergamot Essential Oil), Aloe Barbadensis Leaf Juice (Organic Aloe), Glycerin (Moisturizer)

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact the poison control center immediately.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Ethanol 65%. Wipe hands thoroughly. Discard after use.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 wipes; NDC: 82311-0102-1

BIOM02 Bergamot Bloom - sanitising alcohol wipesBIOM02 Bergamot Bloom - sanitising alcohol wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82311-0102-1biom Sanitizing Alcohol Wipes - Bergamot Bloom263 mL in 1 PACKAGESWAB2634

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82311-0102BIOM SANITIZING ALCOHOL WIPES - BERGAMOT BLOOM (ALCOHOL) SWAB [BIOM INNOVATIONS INC]4Legacy NDC, 1 package rows20241225_cd97dd56-415e-650a-e053-2995a90a1e88.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82311-010282311-0102-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2a02b25d-7030-801c-e063-6294a90aa2a7cd97dd56-415e-650a-e053-2995a90a1e882024-12-24WarningsExact identifier
spl id: 2a02b25d-7030-801c-e063-6294a90aa2a7
spl set id: cd97dd56-415e-650a-e053-2995a90a1e88