Sani Spire Hand Sanitizer Gel

Sani Spire Hand Sanitizer by

Drug Labeling and Warnings

Sani Spire Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Kira Labs Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SANI SPIRE HAND SANITIZER- alcohol gel 
Kira 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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Sani Spire Hand Sanitizer Gel

DRUG FACTS

Active ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Use(s)

Hand Sanitizer to help decrease bacteria on skin.

Warnings

Flammable. Keep away from fire or flame.

For external use only.

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 immediately.

Directions

Put enough product in your palm to cover hands and rub hands together until dry.

Children under 6 years should be supervised when using this product.

Other information

Do not store above 104°F / 40°C

Inactive ingredients

Purified Water, Fragrance, PEG-6, Glycerin, AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Propylene Glycol, Aloe Barbadensis Leaf Juice, Tocopherol

Package Labeling:

SANI SPIRE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77816-511
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TOCOPHEROL (UNII: R0ZB2556P8)
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77816-511-05	960 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/10/2020	08/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/10/2020	08/31/2022

Labeler - Kira Labs Inc (132579397)

Revised: 7/2021

Document Id: c6ef5838-a4fb-5c36-e053-2995a90a57ff

34390-5

Set id: b1b69a37-6cc8-fa8a-e053-2995a90a49f5

Version: 2

Effective Time: 20210712