Itty Bitty SPIDER HAND SANITIZER GEL

Itty Bitty SPIDER HAND SANITIZER by

Drug Labeling and Warnings

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

Drug Details [pdf]

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 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

water, carbomer, glycerin, triethanolamine, mannitol, cellulose, hydroxypropyl methylcellulose, retinyl palmitate, tocopheryl acetate, ultramarines, iodopropynyl butyl carbamate, methylisothiazolinone

*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 AM - 5 PM

Stop The Spread

Distributed by: Itty Bitty Spider, LLC

Las Vegas, NV 89134

Manufactured by: Welburn Global

Made In Guatamala   IttyBittySpider.com

*effective at eliminating over 99.9% of many common harmful germs

Packaging

ITTY BITTY SPIDER HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78961-814
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
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
MANNITOL (UNII: 3OWL53L36A)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ULTRAMARINE BLUE (UNII: I39WR998BI)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78961-814-01	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/28/2020	12/31/2021
2	NDC: 78961-814-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/28/2020	12/31/2021
3	NDC: 78961-814-04	119 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/28/2020	12/31/2021
4	NDC: 78961-814-08	239 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/28/2020	12/31/2021
5	NDC: 78961-814-12	359 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/28/2020	12/31/2021
6	NDC: 78961-814-16	479 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/28/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/28/2020	12/31/2021

Labeler - Itty Bitty Spider (005675080)

Revised: 1/2022

Document Id: 0e6ca94f-3879-4fc7-8781-33184946d381

34390-5

Set id: 64d1f5eb-3c86-4d71-bb80-4ca5a2e33332

Version: 2

Effective Time: 20220117