SUCTION SWABS WITH PEROX-A-MINT SOLUTION- 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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Suction Swabs with Perox-A-Mint® Solution

Drug Facts

Suction Swab with Perox-A-Mint Solution
Active Ingredient: 
PEROX-A-MINT:
Purpose
Hydrogen Peroxide 1.5%Oral Debriding Agent

Uses

Warnings

Stop use and ask a doctor if:

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

Suction Swabs with Perox-A-Mint solution and Mouth Moisturizer

Suction Swabs with Perox-A-Mint solution

Inactive Ingredients

Water, menthol flavor, polysorbate 80, phosphoric acid, sodium saccharin, Blue 1 (CI 42090), Yellow 6 (CI 15985).

Questions? Call toll-free 800-323-2220.

Suction Swabs with Perox-A-Mint Solution

Suction Swab drug facts 6513Suction Swab drug facts 6512Perox-A-Mint Solution

SUCTION SWABS WITH PEROX-A-MINT SOLUTION 
hydrogen peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-813
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53462-813-601 in 1 KIT; Type 1: Convenience Kit of Co-Package06/28/2002
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKET 2 g
Part 2
Part 31 PACKET 7 mL
Part 1 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
12 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic
Part 2 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
Part 3 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)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
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
17 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/21/1998
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/28/2002
Labeler - Sage Products LLC (054326178)
Registrant - Sage Products LLC (054326178)
Establishment
NameAddressID/FEIBusiness Operations
Sage Products LLC054326178manufacture(53462-813, 53462-075)

Revised: 5/2018
Document Id: 6b3ec25a-65be-de80-e053-2991aa0aa70d
Set id: de3aa385-0f73-49e5-8de5-027b10721f01
Version: 6
Effective Time: 20180502
 
Sage Products LLC