Neova Breakout Control

Dosage form: swab
Ingredients: Salicylic Acid 2mL in 100mL
Labeler: PhotoMedex, Inc.
NDC Code: 62362-119

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.

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.jpg

NEOVA   BREAKOUT CONTROL
salicylic acid swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62362-119
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (Salicylic Acid) Salicylic Acid2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Allantoin 
Hamamelis Virginiana Leaf Water 
Aloe Vera Leaf 
Isoceteth-20 
Methyl Gluceth-20 
Polyethylene Glycol 300  
Propylene Glycol 
Sodium Hydroxide 
Sodium Pyrrolidone Carboxylate 
Sorbitol 
Edetate Sodium 
Water 
Packaging
#Item CodePackage Description
1NDC:62362-119-3636 APPLICATOR (APPLICATOR) 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/FEIOperations
PhotoMedex, Inc.054503875manufacture

Revised: 12/2011
 
PhotoMedex, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)