TSC Hand Sanitizer Unscented

TSC Hand Sanitizer Unscented by

Drug Labeling and Warnings

TSC Hand Sanitizer Unscented by is a Otc medication manufactured, distributed, or labeled by TS Cosmetic Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TSC HAND SANITIZER UNSCENTED- alcohol gel 
TS Cosmetic Labs, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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TSC Hand Sanitizer Unscented

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)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

Warnings

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

Do not use

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

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.

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.

Directions

• 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

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

Inactive ingredients

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

Package Label - Principal Display Panel

NDC: 78056-080-02

2oz | 60 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

TSC HAND SANITIZER UNSCENTED 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78056-999
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.005 mL  in 100 mL
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)	0.005 mL  in 100 mL
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	0.5 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.1 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.5 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.3 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	2 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78056-999-08	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/15/2020
2	NDC: 78056-999-02	60 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/15/2020
3	NDC: 78056-999-16	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/15/2020
4	NDC: 78056-999-32	946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/15/2020
5	NDC: 78056-999-01	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/15/2020	02/17/2021

Labeler - TS Cosmetic Labs, Inc. (932962132)

Revised: 7/2021

Document Id: c73296a1-533e-25bf-e053-2a95a90a8520

34390-5

Set id: aad06973-4046-8ff3-e053-2a95a90af6ce

Version: 2

Effective Time: 20210715