TSC Hand Sanitizer Gel

Manufacturer
TS Cosmetic Labs, Inc.
Effective date
2020-05-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:29:23

Label at a glance#

ProductTSC Hand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer gel-base 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.

This hand sanitizer gel-base is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation):

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (2.00% v/v).
  3. Carbomer Homopolymer Type C (0.30% v/v).
  4. Propylene Glycol (0.50% v/v).
  5. Aminomethyl propanol (0.10% v/v).
  6. Vitamin E (0.005% v/v).
  7. Aloe Vera Leaf (0.005% v/v).
  8. Isopropyl Myristate (0.5% v/v)
  9. Fragrance Cucumber (0.004% v/v)
  10. FD&C Blue no. 1 and FD&C Yellow no. 5
  11. Sterile distilled water or boiled cold water.

This firm does not add other active or inactive ingredients than stated above.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of 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.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin,carbomer homopolymer type C, propglene glycol, aminomethyl propanol, vitamin e, aloe vera leaf, fragrance, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 78056-080-02

2oz | 59 mL

NDC: 78056-080-08

8oz | 236 mL

NDC: 78056-080-16

16oz | 473 mL

NDC: 78056-080-32

32 oz | 946 mL

NDC: 78056-080-01

1 Gal. | 3785 mL

60 ml label60 ml label236 ml label236 ml label473 ml label473 ml label946 ml label946 ml label3785 ml label3785 ml label

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78056-88878056-888-08, 78056-888-02, 78056-888-16, 78056-888-32, 78056-888-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
c732af59-5514-7c06-e053-2a95a90a3c8ba6443fc8-b6b6-16dc-e053-2995a90a04c72021-07-15WarningsExact identifier
spl set id: a6443fc8-b6b6-16dc-e053-2995a90a04c7

Reported adverse events (FAERS/openFDA)#

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