DERMESSE PAD TREATMENT 0.5- 0.5%salicylic acid lotion 
DERMESSE PAD TREATMENT 2.0- 2%salicylic acid lotion 
Axia Medical Solutions, 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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Dermesse Pad Treatment

Active Ingredients

0.5% Salicylic Acid

2% Salicylic Acid

Purpose

Acne Treatment

Uses:

For the treatment of acne

Warninigs:

For external use only

Combustibles. Keep away from fire or flames.

Ask a doctor or pharmacist before use if you are:

using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs only one medication should be used unless directed by a doctor.

Keep out of reach of children

If swallowed get medical help or contact a Poison Control center right away.

DIRECTIONS:

OTHER INFORMATION:

Store at controlled room temperature 15-300C (59-860F), away from diret sunlight.

INACTIVE INGREDIENTS:

Ammonium Hydroxide, Edetate Disodium, Ethyl Alcohol SD40, Glycolic Acid, Propylene Glycol, Purified Water, Nonoxynol 9.

Dermesse Pad Treatment 0.5

Dermesse_AcnePads_0.5%

Dermesse Pad Treatment 2.0

Dermesse_AcnePads_2.0%

DERMESSE PAD TREATMENT 0.5 
0.5%salicylic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68723-400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
AMMONIA (UNII: 5138Q19F1X)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68723-400-0560 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package01/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/2022
DERMESSE PAD TREATMENT 2.0 
2%salicylic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68723-401
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
AMMONIA (UNII: 5138Q19F1X)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68723-401-2060 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package01/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/2022
Labeler - Axia Medical Solutions, LLC (929224694)
Registrant - Axia Medical Solutions, LLC (929224694)
Establishment
NameAddressID/FEIBusiness Operations
Sanitor Corporation797472792manufacture(68723-400, 68723-401)

Revised: 1/2022
Document Id: c9ec196d-bd55-470d-9165-836c54c7cd81
Set id: 959c44cd-c067-4bd1-b46b-5fccf4802ef7
Version: 1
Effective Time: 20220111
 
Axia Medical Solutions, LLC