Crosstex Sanityze Hand Sanitizer Gel

Sanityze by

Drug Labeling and Warnings

Sanityze by is a Otc medication manufactured, distributed, or labeled by Crosstex International Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SANITYZE HAND SANITIZER- alcohol gel 
Crosstex International 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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Crosstex Sanityze Hand Sanitizer Gel

Drug Facts

Active ingredient

Alcohol 70% v/v

Purpose

Antiseptic

Uses

• to decrease bacteria on the skin that potentially can cause disease
• recommended for repeated use

Warnings

For external use only

Flammable,keep away from heat or flame

When using this product, keep away from eyes. In case of eye contact, rinse eyes with water.

Stop use and ask a doctor if irritation and redness develop or lasts more than 72 hours.

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

Directions

• apply liberally to hands to cover all surfaces
• rub hands together until dry

Other Information may stain some fabrics.

Inactive ingredients water, isopropyl alcohol, PEG/PPG-18/18 Dimethicone, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, triethanolamine, alpha tocopherol (Vitamin E), aloe barbadensis leaf juice, FD&C yellow 5, FD&C blue 1

CROSSTEX

Manufactured for: Crosstex International, Inc.

6789 W. Henrietta Road, Rush, NY 14543 USA

585.359.0130 | 631.582.6777 Ì crosstex.com

Made in USA from globally sourced materials.

SaniTyze™

Hand Sanitizer with Aloe Vera & Vitamin E

Developed for Healthcare Professionals

18 fl. oz. (532mL)

SANITYZE  HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24794-400
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
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24794-400-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2021	07/30/2021
2	NDC: 24794-400-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2021	07/30/2021
3	NDC: 24794-400-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2021	04/15/2023
4	NDC: 24794-400-18	532 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2021	04/19/2023
5	NDC: 24794-400-28	800 mL in 1 POUCH; Type 0: Not a Combination Product	01/27/2021	07/30/2021
6	NDC: 24794-400-34	1000 mL in 1 POUCH; Type 0: Not a Combination Product	01/27/2021	03/18/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/27/2021	04/19/2023

Labeler - Crosstex International Inc. (057728685)

Revised: 9/2022

Document Id: e99b1037-8e25-c88f-e053-2a95a90a1a0d

34390-5

Set id: b9e4dc63-6685-79ce-e053-2995a90ad41d

Version: 3

Effective Time: 20220926