Oriox Cool Breath Oral Rinse Mild by LCC LTD

Oriox Cool Breath Oral Rinse Mild by

Drug Labeling and Warnings

Oriox Cool Breath Oral Rinse Mild by is a Otc medication manufactured, distributed, or labeled by LCC LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ORIOX COOL BREATH ORAL RINSE MILD- allantoin liquid 
LCC LTD

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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allantoin

Package Label - Principal Display Panel

ORIOX COOL BREATH ORAL RINSE MILD 
allantoin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77932-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POLOXAMER 407 (UNII: TUF2IVW3M2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77932-002-01	1500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2022	09/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/31/2022	09/02/2024

Labeler - LCC LTD (688785286)

Establishment
Name	Address	ID/FEI	Business Operations
LCC LTD		688785286	manufacture(77932-002)

Revised: 9/2024

Document Id: 211e13f4-53ee-cef1-e063-6294a90a5ad5

34390-5

Set id: db7f0cdc-fa16-38e7-e053-2995a90a9a95

Version: 3

Effective Time: 20240902