ADVANCE ACNE CARE- salicylic acid, silver 
Swabplus Inc.

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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Advance Acne Care Swab

Drug Facts
Active Ingredients

Advance Acne Care Swabs step 1

Silver 0.001%

Advance Acne Care Swabs Step 2

Salicylic Acid 2.0%

Purpose

For skin acne medication

Uses

When using this product. Avoid contact with eyes. If contact occures. flush throughly with water. Using other topical acne medications at teh same time or immediately following use this product may increase dryness or irrtation of the skin. If this occures, only one medication shoukld be used unless directed by a doctor. Do not insert in teh canal.

Keep out of reach of children

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

Directions

Warnings

For external use only.

Other information

Avoid storing at excessive heat.

Inactive Ingredients

Allantoin, Aloe Vera leaf Juice, Diazolidinyl Urea, Isoceteth-20, Methyl Gluceth-20, Methylparaben, Propylene Glycol, Propylparaben, Red 33, Red 40, Sodium Hydroxide, Sodium PCA, Sorbitol, Tetrasodium EDTA, Water, Witch Hazel.

Water, Sodium Lauryl Sulfate, Citric Acid, Silver.

Package carton

Image of Acne Care CartonImage of Acne Care Carton

ADVANCE ACNE CARE 
salicylic acid, silver kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65734-740
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65734-740-001 in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 113 APPLICATOR 2 mL
Part 213 APPLICATOR 2 mL
Part 1 of 2
ACNE CARE SWAB STEP 1 CLEAN 
silver solution
Product Information
Item Code (Source)NDC:65734-741
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER0.1 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65734-741-2424 in 1 PACKAGE
1NDC:65734-741-000.15 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/07/2008
Part 2 of 2
ACNE CARE SWAB STEP 2 TREAT 
salicylic acid solution
Product Information
Item Code (Source)NDC:65734-742
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
ISOCETETH-20 (UNII: O020065R7Z)  
METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM (UNII: 9NEZ333N27)  
SORBITAN (UNII: 6O92ICV9RU)  
WATER (UNII: 059QF0KO0R)  
WITCH HAZEL (UNII: 101I4J0U34)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65734-742-2424 in 1 PACKAGE
1NDC:65734-742-000.15 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/07/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/07/2008
Labeler - Swabplus Inc. (876441549)
Registrant - Swabplus Inc. (876441549)
Establishment
NameAddressID/FEIBusiness Operations
Swabplus Inc.876441549repack(65734-740) , manufacture(65734-741, 65734-742)

Revised: 3/2015
Document Id: 6f8925f9-5bce-4dba-aeca-1887b252b614
Set id: 4e82ba38-c094-42c1-8b5a-10805034bbab
Version: 1
Effective Time: 20150323
 
Swabplus Inc.