THAILUV- alcohol gel
THAILUV LLC

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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THAILUV

Active Ingredient

Alcohol 70%

Purpose

Antiseptic

Uses

Recommended for septic hand cleansing. This product does not replace the use of soap and water.
Recommended for repeated use

Warnings

For external use only.

When using this product:
• Keep out of eyes .ln case of accidental contact, flush eyes thouroughly with water for 15 m1nutes.
• Advoid contact with broker skin or if you have allergies to any ing redients

Stop use and consult a doctor if skin irritation occurs

Keep out of reach of children

In case of accidental ingestion drink plenty of water and seek medical help or contact Poison Control Center immediately
External use only

FLAMMABLE: Keep out of heat

Directions

Place a small acount of product in your hand.
Rub hands together briskly for at least 30 seconds until dry.
Children under 6 years of age should use under adult supervision

Questions? 303-257-7630

Inactive Ingredients

Purified water USP, glycerin, carbomer, triethaanolamine

Product Label

image description

THAILUV
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78101-001
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
CARBOMER 940 (UNII: 4Q93RCW27E)
TRIETHANOLAMINE HYDRIODIDE (UNII: DT98IT03JK)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78101-001-01	125 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2020
2	NDC:78101-001-02	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2020
3	NDC:78101-001-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2020
4	NDC:78101-001-04	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2020
5	NDC:78101-001-05	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/20/2020

Labeler - THAILUV LLC (009728757)