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

Label at a glance#

ProductHand Sanitizer

Active ingredientALCOHOL

Label structure12 sections

Dosage and administration

■ 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

Contacts and useful links#

PhoneLabel contact1-800-278-9218

Label contents#

Full prescribing information#

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

package label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
581660	ethanol 62 % Topical Gel	PSN	1
581660	ethanol 0.62 ML/ML Topical Gel	SCD	1
581660	ethanol 62 % Topical Gel	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49852-601-30	2022-01-28	C162847	48780-1	d6a99b39-766d-a426-e053-dadaa90af4c2	TriCstl BBC Hand Santizer 62 Brght Pink

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49852-601-30	Hand Sanitizer	30 mL in 1 BOTTLE, PLASTIC	GEL	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49852-601	HAND SANITIZER (ALCOHOL) GEL [TRI-COASTAL DESIGN COMPANY INC.]	1	Legacy NDC, 1 package rows	20200704_a98ed01f-e4be-2bdf-e053-2995a90a8bb8.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Hand Sanitizer
Alcohol
FD&C RED NO. 40
D&C RED NO. 33
POLYOXYL 40 HYDROGENATED CASTOR OIL
CARBOMER INTERPOLYMER TYPE A (55000 CPS)
WATER
SODIUM HYDROXIDE
DENATONIUM BENZOATE

NDC Codes#

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

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FD&C RED NO. 40	WZB9127XOA	IACT
D&C RED NO. 33	9DBA0SBB0L	IACT
POLYOXYL 40 HYDROGENATED CASTOR OIL	7YC686GQ8F	IACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)	59TL3WG5CO	IACT
WATER	059QF0KO0R	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
ALCOHOL	3K9958V90M	ACTIB
DENATONIUM BENZOATE	4YK5Z54AT2	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a98ec1c1-6570-2719-e053-2a95a90a6019			a98ed01f-e4be-2bdf-e053-2995a90a8bb8	2020-07-03	Warnings	Exact identifier spl id: a98ec1c1-6570-2719-e053-2a95a90a6019 spl set id: a98ed01f-e4be-2bdf-e053-2995a90a8bb8

Reported adverse events (FAERS/openFDA)#

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