ITTY BITTY SPIDER HAND SANITIZER- ethyl alcohol gel
Itty Bitty Spider

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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Itty Bitty SPIDER HAND SANITIZER GEL

Drug Facts

Active ingredient

Ethyl alcohol 72% v/v

Purpose

Antiseptic

Uses • hand sanitizer to decrease bacteria on the skin • recommended for repeated use • for use when soap and water are not available

Warnings

Flammable, keep away from fire/flame
For external use only

Do not use • in children less than 2 months of age • on open skin wounds

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if • irritation and redness develop • condition persists for more than 72 hours

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

Directions • wet hands thoroughly with product and allow to dry without wiping • supervise children under 6 years of age when using this product to avoid swallowing

Other information • store between 20-25°C (68-77°F) • avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

ethyl acrylate copolymer*, ethyl methacrylate*, fragrance (perfum), glycerin, purified water USP, triethanolamine

*Contains one or more of these ingredients

Questions? +1-432-296-9950

You may also report serious side effects to this phone number.
Mon-Fri 9:00 AM - 5:00 PM

Stop The Spread

Distributed by: Itty Bitty Spider, LLC
Las Vegas, NV 89134

Manufactured by: Genesis
IttyBittySpider.com

Made in the USA

Packaging

ITTY BITTY SPIDER HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78961-611
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	72 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78961-611-01	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/08/2020
2	NDC:78961-611-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/08/2020
3	NDC:78961-611-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/08/2020
4	NDC:78961-611-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/08/2020
5	NDC:78961-611-64	1893 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/08/2020
6	NDC:78961-611-28	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/08/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/08/2020

Labeler - Itty Bitty Spider (005675080)

Revised: 9/2020

Document Id: af551ecd-4865-4453-be2b-2a9f989314e9

Set id: d4857d18-3b76-4869-b09b-e8c859d63735

Version: 1

Effective Time: 20200907

Itty Bitty Spider