biom Sanitizing Alcohol Wipes - Tea Tree Bliss

Manufacturer
Biom Innovations Inc
Effective date
2024-12-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:48:15

Label at a glance#

Productbiom Sanitizing Alcohol Wipes - Tea Tree Bliss
Active ingredientALCOHOL
Label structure10 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This is a hand sanitizer manufactured in compliance with (the now withdrawn) Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.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%, (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.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 redness or irritation develops and continues for more than 72 hours.

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, Tea Tree Oil, Aloe Barbadensis Leaf Juice (Organic Aloe), Glycerin (Moisturizer)

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: 82311-0118-1, Hand Sanitizing Tea Tree Bliss Hand Sanitizing - 50 wipe Tea Tree BlissHand Sanitizing - 50 wipe Tea Tree Bliss

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82311-0118-1biom Sanitizing Alcohol Wipes - Tea Tree Bliss263 mL in 1 PACKAGESWAB2632

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82311-0118BIOM SANITIZING ALCOHOL WIPES - TEA TREE BLISS (ALCOHOL) SWAB [BIOM INNOVATIONS INC]21 package rows20241225_07fca711-e40d-bb9a-e063-6394a90af600.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
82311-011882311-0118-1

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
2a027624-8c65-5ea9-e063-6294a90ab86907fca711-e40d-bb9a-e063-6394a90af6002024-12-24WarningsExact identifier
spl id: 2a027624-8c65-5ea9-e063-6294a90ab869
spl set id: 07fca711-e40d-bb9a-e063-6394a90af600

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.