ADVANCE ACNE CARE- salicylic acid, silver kit

Advance Acne Care by

Drug Labeling and Warnings

Advance Acne Care by is a Otc medication manufactured, distributed, or labeled by Swabplus Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug FactsActive 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

• Do not use if label seal is broken prior to purchase.Keep swabs in original container when not in use. Treatment Swabs have a red color band.
• Use Cleansinh swab to cleanse the skin throughly before applying medication.
• Hold the swab vertically, with the color ring band tip upwards. 
• Bend the tip at the color band to one side until it snaps. Medicine will flow to theother end.
• Cover the entire affected area with a thin layer 1 to 3 times daily. Discard swab after use.
• Each swab can be used on multipe pimples.
• Because excesssive drying of the skin may occur start with1 application daiky then gradually increase to 2 or 3 times daily if needed, or as direcvted by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every othr day. 

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 Carton

INGREDIENTS AND APPEARANCE

ADVANCE ACNE CARE 
salicylic acid, silver kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65734-740

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65734-740-00	1 in 1 CARTON

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	13 APPLICATOR	2 mL
Part 2	13 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 Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G)	SILVER	0.1 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65734-741-24	24 in 1 PACKAGE
1	NDC: 65734-741-00	0.15 mL in 1 APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/07/2008

Part 2 of 2

ACNE CARE SWAB STEP 2 TREAT 
salicylic acid solution

Product Information
Item Code (Source)	NDC: 65734-742
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65734-742-24	24 in 1 PACKAGE
1	NDC: 65734-742-00	0.15 mL in 1 APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	08/07/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	08/07/2008

Labeler - Swabplus Inc. (876441549)

Registrant - Swabplus Inc. (876441549)

Establishment
Name	Address	ID/FEI	Business Operations
Swabplus Inc.		876441549	repack(65734-740) , manufacture(65734-741, 65734-742)