NEOVA BREAKOUT CONTROL- salicylic acid swab

Neova by

Drug Labeling and Warnings

Neova by is a Otc medication manufactured, distributed, or labeled by PhotoMedex, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

NEOVA   BREAKOUT CONTROL
salicylic acid swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62362-119
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	2 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62362-119-36	36 in 1 BOX
1	NDC: 62362-119-05	5 mL in 1 APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358B	12/27/2011

Labeler - PhotoMedex, Inc. (054503875)

Establishment
Name	Address	ID/FEI	Business Operations
PhotoMedex, Inc.		054503875	manufacture