UltraCruz Hand Sanitizing Gel by Santa Cruz Biotechnology, Inc. Discontinued Product

UltraCruz Hand Sanitizing Gel by

Drug Labeling and Warnings

UltraCruz Hand Sanitizing Gel by is a Otc medication manufactured, distributed, or labeled by Santa Cruz Biotechnology, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ULTRACRUZ HAND SANITIZING GEL- isopropyl alcohol gel 
Santa Cruz Biotechnology, 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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Discontinued Product

UltraCruz Hand Sanitizing Gel

This is a hand sanitizer manufactured according to the Tentative Final Monograph for TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE, Title 21, PART 333, CFR

Title 21
Volume 5
Chapter I
Subchapter D
Part 333

Part 333 - Topical Antimicrobial Drug Products For Over-the-counter Human Use

PART 333 - TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Authority:21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Source:52 FR 47322, Dec. 11, 1987, unless otherwise noted.

Three sizes.

(1)

89 ml NDC: 90032-214-83

UltraCruz Hand Sanitizing Gel

Santa Cruz Biotechnology, Inc.

Antimicrobial

3 FLUID OZ/89 ML

(2)

237 ml NDC: 90032-214-08

UltraCruz Hand Sanitizing Gel

Santa Cruz Biotechnology, Inc.

Antimicrobial

8 FLUID OZ/237 ML

(3)

3.8 L NDC: 90032-214-94

UltraCruz Hand Sanitizing Gel

Santa Cruz Biotechnology, Inc.

Antimicrobial

1 GALLON (3.8 L)

Active Ingredient(s)

70% Isopropyl Alcohol. Purpose: Antimicrobial

Purpose

Antimicrobial

Use

Hand Sanitizer to help reduce bacteria on the skin. Recommended for repeated use.

Warnings

Flammable. Keep away from open flame.

For external use on the hands only.

Avoid contact with eyes. If eye contact occurs, flush with water.

Stop and ask a doctor if irritation or rash appears and lasts.

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

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

Directions

• Place a palmful of product in one hand. Spread on both hands and rub into the skin until dry.
• Children under 6 years of age should be supervised when using.

Other information

• Store below 110F (43C)
• May discolor fabrics or surfaces.

Inactive ingredients

Water (Purified), Aloe Vera, Propylene Glycol, Vitamin E (dl-Alpha-Tocopherol Acetate), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Dimethicone, Triisopropanolamine.

Additional Label Text, Description

Kills most common germs that may cause illness. Can be used anytime, any place. Contains moisturizers and Vitamin E to leave hands feeling refreshed, soft and smooth without stickiness or residue.

MANUFACTURED BY:

Santa Cruz Biotechnology, Inc.

10410 Finnell Street, Dallas, TX 75220

1.800.457.3801 l www.scbt.com

Package Label - Principal Display Panel

89 ml NDC: 90032-214-83

237 ml NDC: 90032-214-08

3800 mL NDC: 90032-214-94

ULTRACRUZ HAND SANITIZING GEL 
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90032-214
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	17.4585 g  in 29.6 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)	0.08 g  in 29.6 mL
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)	0.14 g  in 29.6 mL
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)	0.0225 g  in 29.6 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.18 g  in 29.6 mL
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)	0.1 g  in 29.6 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.15 g  in 29.6 mL
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90032-214-83	89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/10/2020
2	NDC: 90032-214-08	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/26/2020
3	NDC: 90032-214-94	3800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/10/2020	12/27/2022

Labeler - Santa Cruz Biotechnology, Inc. (782655427)

Establishment
Name	Address	ID/FEI	Business Operations
Santa Cruz Biotechnology, Inc.		782655427	manufacture(90032-214)

Revised: 12/2022

Document Id: f0d38b9b-2ac1-7664-e053-2a95a90ac87c

34390-5

Set id: abb09c54-bfef-712f-e053-2995a90a6551

Version: 2

Effective Time: 20221227