Hand Sanitizer

Manufacturer
Tri-Coastal Design Company Inc.
Effective date
2020-07-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:20:05

Key Label Information#

Active Ingredients And Purpose

Active ingredient

Alcohol Denat 62%

Purpose

Antiseptic

Uses

Use

■ For handwashing to decrease bacteria on the skin ■ Recommended for repeated use

Warnings

Warnings

■ For external use only ■ Flammable, keep away from fire & flame ■ Does not contain grain alcohol;do not drink. If taken internally will produce serious gastric disturbances.

Stop use and ask a doctor if

■ Condition worsens ■ Redness or irritation develops ■ If condition persists for more than 3 days

Directions And Dosage

Directions

■ Rub dime sized amount between hands until dry ■ Supervise children in the use of this product ■ In the case of eye contact, rinse eyes thoroughly with water

Other Label Information

Inactive Ingredients

Water, Fragrance, PEG-40 Hydrogenated Castor Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Denatonium Benzoate, D&C Red No. 33(CI 17200), FD&C Red No. 40(CI 16035)

Questions?

■ 1-800-278-9218

Package Label

Label Images#

HndSntzr62BrghtPnk
HndSntzr62BrghtPnk

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN1
581660ethanol 0.62 ML/ML Topical GelSCD1
581660ethanol 62 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49852-601-302022-01-28C16284748780-1d6a99b39-766d-a426-e053-dadaa90af4c2TriCstl BBC Hand Santizer 62 Brght Pink

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49852-601-30Hand Sanitizer30 mL in 1 BOTTLE, PLASTICGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49852-601HAND SANITIZER (ALCOHOL) GEL [TRI-COASTAL DESIGN COMPANY INC.]1Legacy NDC, 1 package rows20200704_a98ed01f-e4be-2bdf-e053-2995a90a8bb8.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49852-60149852-601-30

Ingredients#

Complete SPL Sections#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol Denat 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

■ For handwashing to decrease bacteria on the skin ■ Recommended for repeated use

Warnings

WARNINGS SECTION

■ For external use only ■ Flammable, keep away from fire & flame ■ Does not contain grain alcohol;do not drink. If taken internally will produce serious gastric disturbances.

When using this product

OTC - WHEN USING SECTION

■ Avoid the eyes and mucous membranes ■ In the case of eyes or mucous membrane contact, rinse area thoroughly with water

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ Condition worsens ■ Redness or irritation develops ■ If condition persists for more than 3 days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

■ If swallowed contact a doctor or Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Rub dime sized amount between hands until dry ■ Supervise children in the use of this product ■ In the case of eye contact, rinse eyes thoroughly with water

Other information

SPL UNCLASSIFIED SECTION

■ Store below 105°F ■ May discolor some fabrics

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Fragrance, PEG-40 Hydrogenated Castor Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Denatonium Benzoate, D&C Red No. 33(CI 17200), FD&C Red No. 40(CI 16035)

Questions?

OTC - QUESTIONS SECTION

■ 1-800-278-9218

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML