ORAL SORE ANTISEPTIC- hydrogen peroxide, menthol liquid 
RETAIL BUSINESS SERVICES , 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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Oral Sore Antiseptic Rinse
024.000/024AA-AB

Active ingredients

Hydrogen peroxide 1.5% (w/v)

Menthol 0.1% (w/v)

Purpose

Oral debriding agent/Oral antiseptic
Oral pain reliever

Uses

▪ first aid to help protect against bacterial contamination in minor oral wounds


▪ for temporary pain relief and ▪ temporary use in cleansing minor wounds or
minor gum inflammation resulting from: ▪ minor dental procedures ▪ dentures
▪ orthodontic appliances ▪ accidental injury ▪ other irritations of the mouth
and gums ▪ canker sores


▪ aids in the removal of: ▪ phlegm ▪ mucus ▪ other secretions associated with
occasional sore mouth

Warnings

for this product

Stop use and ask a doctor if

▪ sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting
▪ irritation, pain, or redness persists or worsens
▪ swelling, rash, or fever develops
▪ sore mouth symptoms do not improve in 7 days

When using this product

Keep out of reach of children

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Directions

Adults and children 2 years of age and older - swish two teaspoons (10 mL) around the mouth for at least 1 minute, then spit out; use up to 4 times daily or as directed by a dentist or physician

Children under 12 years of age - should be supervised in the use of the product

Children under 2 years of age - consult a dentist or doctor

Other information

Inactive ingredients

alcohol (4.1% v/v), blue 1, disodium EDTA, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, sodium saccharin, sorbitol, water

DISTRIBUTED BY ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

For product questions or concerns,

contact us at 1-833-992-3872

Quality guarenteed or your money back.

*This product is not manufactured or distributed by Church & Dwight Co., Inc. distributor of Orajel Antiseptic Rinse Mouth Sores.

DSP-TN-21091   DSP-MO-20087

Principal display panel

CAREONE

Compare to Orajel Antispetic Rinse Mouth Sores*

ORAL SORE

ANTISEPTIC RINSE

ORAL PAIN RELIEVER

ORAL DEBRIDING AGENT

FOR MOUTH SORES, INCLUDING GUM IRRITATIONS FROM BRACES OR DENTURES AND CANKER SORES

MINT FLAVOR

Sealed With Printed Neckband For Your Protection

NET 16 FL OZ (1 PT) 473 mL

image description

ORAL SORE ANTISEPTIC 
hydrogen peroxide, menthol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-024
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE15 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
POLOXAMER 338 (UNII: F75JV2T505)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72476-024-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/13/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/13/2023
Labeler - RETAIL BUSINESS SERVICES , LLC (967989935)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
VI-Jon, LLC790752542manufacture(72476-024)
Establishment
NameAddressID/FEIBusiness Operations
VI-Jon, LLC088520668manufacture(72476-024)

Revised: 4/2023
Document Id: 5f1de15d-0244-4f6c-a72e-7a369e4cae51
Set id: d46546d0-c6df-431a-8ab0-bc5013c084d7
Version: 2
Effective Time: 20230421
 
RETAIL BUSINESS SERVICES , LLC