Hydrel by Paradigm Labs, Inc. Hydrel

Hydrel by

Drug Labeling and Warnings

Hydrel by is a Otc medication manufactured, distributed, or labeled by Paradigm Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HYDREL- alcohol gel 
Paradigm Labs, 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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Hydrel

Active Ingredient(s)

Alcohol 65% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer is used to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do not use

On children less than 2 months of age

On open skin wounds

When using this product: keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Stop using and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

Directions

Depress sprayer lightly for stream, or depress firmly for spray.

Place enough product on hands to cover. Rub hands together until dry.

Supervise children under 6 years of age when using this product.

Inactive Ingredients

Purified water USP, isopropyl alcohol, glycerin, carbomer, hydrogen peroxide, triisopropylamine

Package Label - Principal Display Panel

100 ml NDC: 78918-901-01

3785 ml NDC: 78918-901-03

HYDREL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78918-901
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.15 mL  in 100 mL
ALOE (UNII: V5VD430YW9)	0.25 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.9 mL  in 100 mL
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)	0.05 mL  in 100 mL
CARBOMER 980 (UNII: 4Q93RCW27E)	0.25 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78918-901-01	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/08/2020
2	NDC: 78918-901-03	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2020
3	NDC: 78918-901-02	236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/08/2020
4	NDC: 78918-901-04	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2020
5	NDC: 78918-901-05	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/08/2020	12/31/2023

Labeler - Paradigm Labs, Inc. (783327760)

Establishment
Name	Address	ID/FEI	Business Operations
Paradigm Labs, Inc.		783327760	manufacture(78918-901)

Revised: 11/2021

Document Id: d12849b5-4567-692c-e053-2a95a90ad407

34390-5

Set id: a9f6e8a9-3bfb-b2d7-e053-2995a90abdb5

Version: 4

Effective Time: 20211119