HAND SANITIZER- alcohol gel
Dr.Sankunnis Ayurvedic Research Foundation Pvt Ltd

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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Hand Sanitizer

Active Ingredient(s)

Alcohol 70% v/v.

Purpose

Antimicrobial

Use

Hand Sanitizer to help reduce bacteria that potentially could cause disease. Recommended for repeated use

Warnings

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

When using this product do not use in or near the eyes. In case of contact, 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.

Directions

Place enough product on hands to cover your hands. Rub hands briskly until dry.
No rinsing required
No towels needed

Other information

Do not store above 110F (43C)
May discolor certain fabrics or surfaces

Inactive ingredients

Vitamin E, Demineralized Water, Glycerin

Package Label - Principal Display Panel

label label 1

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70146-012
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
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70146-012-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC:70146-012-02	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC:70146-012-03	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
4	NDC:70146-012-04	5000 mL in 1 JUG; Type 0: Not a Combination Product	03/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020

Labeler - Dr.Sankunnis Ayurvedic Research Foundation Pvt Ltd (650517704)

Name	Address	ID/FEI	Business Operations
Establishment
Dr.Sankunnis Ayurvedic Research Foundation Pvt Ltd		650517704	manufacture(70146-012)