SHORT TERM ORAL SWAB SYSTEM- hydrogen peroxide 
Sage Products 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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Short Term Oral Swab System

Drug Facts

 Active Ingredient Purpose
 PEROX-A-MINT SOLUTION:
 1.5% Hydrogen peroxide Oral debriding agent

Use

Aids in the removal of debris and secretions.

Warnings

Stop use and ask a doctor if:

  • Sore mouth symptoms do not improve in 7 days.
  • Swelling, rash or fever develops.
  • Irritation, pain or redness persists or worsens.

Keep out of reach of children.

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

Directions

Oral Swab System

  • Dip an Oral Swab into the Perox-A-Mint solution.
  • Clean teeth and oral cavity for approximately 1 minute.
  • Instruct to expectorate.
  • Apply Mouth Moisturizer as needed.
  • Discard after use.
  • Swabs are intended for single oral use only.
  • Use up to 4 times daily or as directed by a dentist or doctor.
  • Children under 12 years of age: supervise use.
  • Children under 3 years of age: consult a dentist or doctor.
  • Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.
  • Ensure foam is intact after use. If not, remove any particles from oral cavity.

Inactive Ingredients

Water, menthol flavor, polysorbate 80, phosphoric acid, sodium saccharin, Blue 1 (CI42090), Yellow 6 (CI15985)

Questions

Call toll free 800-323-2220

MADE IN U.S.A.

NOT MADE WITH NATURAL RUBBER LATEX

Short Term Oral Swab System with Perox-A-Mint Solution

Short-Term Oral Swab System Reorder No. 6002

NDC: 53462-023-30

Short Term 6002 bag

Perox-A-Mint Solution Reorder #6065

NDC: 53462-075-30

Perox-A-Mint bottle

SHORT TERM ORAL SWAB SYSTEM 
hydrogen peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-023
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53462-023-301 in 1 KIT; Type 1: Convenience Kit of Co-Package06/30/200704/09/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 44 mL
Part 21 TUBE 14 g
Part 3 1 
Part 1 of 3
PEROX-A-MINT SOLUTION 
hydrogen peroxide mouthwash
Product Information
Item Code (Source)NDC:53462-075
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 KIT
1NDC:53462-075-3044 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/21/1998
Part 2 of 3
MOUTH MOISTURIZER 
other oral hygiene products
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRCOCONUT OIL (UNII: Q9L0O73W7L)  
INGRXYLITOL (UNII: VCQ006KQ1E)  
INGRCARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRWATER (UNII: 059QF0KO0R)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGRPOLYSORBATE 80 (UNII: 6OZP39ZG8H)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRCETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
INGRCARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
INGRSPEARMINT OIL (UNII: C3M81465G5)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 KIT
114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic
Part 3 of 3
SODIUM BICARBONATE 
other oral hygiene products
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRSODIUM BICARBONATE (UNII: 8MDF5V39QO)  
INGRCARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
INGRSODIUM LAURYL SULFATE (UNII: 368GB5141J)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRWATER (UNII: 059QF0KO0R)  
INGRSACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/30/200704/09/2018
Labeler - Sage Products LLC (054326178)
Registrant - Sage Products LLC (054326178)

Revised: 4/2018
Document Id: 6a346e13-ad95-be3a-e053-2991aa0abba6
Set id: c5b092fa-422e-40f4-ac1d-62e30926a8af
Version: 5
Effective Time: 20180419
 
Sage Products LLC