Sanityzeme HAND SANITIZER GEL

Sanityzeme by

Drug Labeling and Warnings

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

Drug Details [pdf]

SANITYZEME- 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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Sanityzeme 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

acrylates vinyl isodecanoate crosspolymer, aloe barbadensis leaf juice, fragrance, glycerin, isopropyl alcohol, 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

SANITYZEME 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78961-122
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: 78961-122-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/27/2020	12/31/2021
2	NDC: 78961-122-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/27/2020	12/31/2021
3	NDC: 78961-122-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/27/2020	12/31/2021
4	NDC: 78961-122-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/27/2020	12/31/2021
5	NDC: 78961-122-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/27/2020	12/31/2021
6	NDC: 78961-122-64	1893 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/27/2020	12/31/2021
7	NDC: 78961-122-28	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/27/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/27/2020	12/31/2021

Labeler - Itty Bitty Spider (005675080)

Revised: 1/2022

Document Id: 992f2e4e-4363-4301-9a93-7617a5c60d47

34390-5

Set id: 1d748274-ea9c-491c-806c-5eacb32b79a0

Version: 2

Effective Time: 20220117