Rejuviel Alcohol-Free by Private Label Productions, LLC

Rejuviel Alcohol-Free by

Drug Labeling and Warnings

Rejuviel Alcohol-Free by is a Otc medication manufactured, distributed, or labeled by Private Label Productions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

REJUVIEL ALCOHOL-FREE- benzalkonium chloride liquid 
Private Label Productions, LLC

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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Drug Facts


Active Ingredients Purpose

Benzalkonium Chloride 0.16%..................Anti-Septic

Uses

Hand sanitizer helps decrease bacteria on skin when soap, water, towel are not available.

​Recommended for repeated use.

Warnings

For external use only.

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts for longer than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Apply as needed onto the palms and thoroughly spread on both hands together briskly until dry. Children under 6 years of age should be supervised when using.

Other information

Store at 20'C (68'F - 77'F). May discolor fabrics.

Inactive Ingredients

Purified Water (aqua), Glycerin, Decyl glucoside, 2-Phenoxyethanol, Citric Acid

Questions or Comments? Call (239) 676-5735 M-F 9am-5pm EST

Distributed by:

Private Label Productions LLC

Bonita Springs, FL 34135

www.rejuviel.com

Made in the USA

Rejuvial

Alcohol-Free

Hand Sanitizer

REJUVIEL ALCOHOL-FREE 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77632-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77632-000-04	118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/03/2020
2	NDC: 77632-000-06	177 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/03/2020
3	NDC: 77632-000-08	237 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/03/2020
4	NDC: 77632-000-12	355 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/03/2020
5	NDC: 77632-000-01	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/03/2020
6	NDC: 77632-000-05	18930 mL in 1 CONTAINER; Type 0: Not a Combination Product	04/03/2020
7	NDC: 77632-000-55	208200 mL in 1 CONTAINER; Type 0: Not a Combination Product	04/03/2020
8	NDC: 77632-000-27	1041000 mL in 1 CONTAINER; Type 0: Not a Combination Product	04/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/03/2020

Labeler - Private Label Productions, LLC (046278265)

Establishment
Name	Address	ID/FEI	Business Operations
Private Label Productions, LLC		046278265	manufacture(77632-000)

Revised: 6/2020

Document Id: a834cca0-7178-e0bc-e053-2a95a90a94d4

34390-5

Set id: a834cca0-7177-e0bc-e053-2a95a90a94d4

Version: 1

Effective Time: 20200616