Itty Bitty SPIDER ANTISEPTIC HAND SANITIZER

Itty Bitty Spider ANTISEPTIC HAND SANITIZER by

Drug Labeling and Warnings

Itty Bitty Spider ANTISEPTIC HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Itty Bitty Spider, Shotwell Hydrogenics, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ITTY BITTY SPIDER ANTISEPTIC 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 ANTISEPTIC HAND SANITIZER

Drug Facts

Active ingredient

Ethyl alcohol 70% 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
acrylates vinyl isodecanoate crosspolymer, aloe barbadensis leaf juice, glycerin, isopropyl alcohol, fragrance, polyethylene glycol, tocopheryl acetate, water

Questions? +1-432-296-9950
You may also report serious side effects to this phone number.
Mon-Fri 9:00 AM - 5:00 PM

with Vitamin E
& Aloe vera

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

Manufactured by: Shotwell Hydrogenics

Made in the USA

IttyBittySpider.com

Packaging

ITTY BITTY SPIDER ANTISEPTIC HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78961-324
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
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78961-324-01	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020	12/31/2021
2	NDC: 78961-324-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020	12/31/2021
3	NDC: 78961-324-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020	12/31/2021
4	NDC: 78961-324-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020	12/31/2021
5	NDC: 78961-324-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020	12/31/2021
6	NDC: 78961-324-64	1893 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020	12/31/2021
7	NDC: 78961-324-28	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/12/2020	12/31/2021

Labeler - Itty Bitty Spider (005675080)

Establishment
Name	Address	ID/FEI	Business Operations
Shotwell Hydrogenics, LLC		108985732	manufacture(78961-324)

Revised: 1/2022

Document Id: 8c1f4f57-6194-437f-8bea-01b3bda9754e

34390-5

Set id: ae990274-e2c8-49b4-a5a9-a58c201088a3

Version: 2

Effective Time: 20220117