Rejuviel by Private Label Productions, LLC

Rejuviel by

Drug Labeling and Warnings

Rejuviel 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 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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Active Ingredients

70% Ethanol (SD Alcohol)

Purpose

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.

Flammable. Keep away from fire or flame.

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 throughly 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), 1,3-Propanediol, PEG600 (PEG-12), Glycerin, Carbomer, Triethanaolamine

Manufactured by / Fabrique par: Private Label Productions LLC, Bonita Springs, FL 34135

With / Avec:

Rejuviel

REJUVIEL 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77632-070
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	700 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
PROPANEDIOL (UNII: 5965N8W85T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77632-070-99	2 mL in 1 PACKET; Type 0: Not a Combination Product	06/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/19/2020	09/07/2023

Labeler - Private Label Productions, LLC (046278265)

Registrant - Private Label Productions, LLC (046278265)

Establishment
Name	Address	ID/FEI	Business Operations
Private Label Productions, LLC		046278265	manufacture(77632-070)

Revised: 9/2023

Document Id: 04bf4c41-dea1-2873-e063-6394a90a9618

34390-5

Set id: a1c7b0b8-c131-9926-e053-2a95a90a0534

Version: 4

Effective Time: 20230907