NEOVA  BREAKOUT CONTROL- salicylic acid swab 
PhotoMedex, 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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Neova Breakout Control - Drug Facts

Active Ingredients

Salicylic Acid 2%

Purpose

Acne Treatment

Uses

• For the treatment of acne. • Helps prevent new acne pimples,
blackheads and whiteheads.

Warnings

For external use only

When using this product

Avoid contact with eyes. If contact occurs, flush
thoroughly with water. Using other topical acne medications at the same time
or immediately following use of this product may increase dryness or
irritation of the skin. If this occurs, only one medication should be used unless
directed by a doctor. Do not insert in ear canal.

Keep out of reach of children.

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

Directions

• Snap the tip at the color ring. • Allow formula to flow down
to the opposite tip. • Apply formula with the saturated tip to affected area.

Other Information

Avoid storing at excessive heat.

Inactive Ingredients

Allantoin, Hamamelis Virginiana (Witch Hazel)
Water, Aloe Barbadensis Leaf Extract, Isoceteth-20, Methyl Gluceth-20, PEG-6,
Propylene Glycol, Sodium Hydroxide, Sodium PCA, Sorbitol, Tetrasodium EDTA,
Water (Aqua).

Image of Box Label

BreakOutControlBoxLabel112611.jpgImage of Box/Label

NEOVA   BREAKOUT CONTROL
salicylic acid swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62362-119
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Allantoin (UNII: 344S277G0Z)  
Hamamelis Virginiana Leaf Water (UNII: 8FP93ED6H2)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Isoceteth-20 (UNII: O020065R7Z)  
Methyl Gluceth-20 (UNII: J3QD0LD11P)  
Polyethylene Glycol 300 (UNII: 5655G9Y8AQ)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
Sorbitol (UNII: 506T60A25R)  
Edetate Sodium (UNII: MP1J8420LU)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62362-119-3636 in 1 BOX
1NDC:62362-119-055 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358B12/27/2011
Labeler - PhotoMedex, Inc. (054503875)
Establishment
NameAddressID/FEIBusiness Operations
PhotoMedex, Inc.054503875manufacture

Revised: 12/2011
Document Id: e42c5d41-b58a-41c1-834b-ea55a83bd685
Set id: 5777250f-9496-47f8-a2f0-294c7c928a47
Version: 2
Effective Time: 20111228
 
PhotoMedex, Inc.