ENFUSELLE ACNE CLARIFYING- salicylic acid lotion

enfuselle Acne Clarifying by

Drug Labeling and Warnings

enfuselle Acne Clarifying by is a Otc medication manufactured, distributed, or labeled by Shaklee Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Salicylic Acid (0.5%)

Purpose

Acne treatment

Uses

For the treatment of acne.

Warnings

• For external use only.

When using this product

• Skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, use only  one topical acne medication at a time.
• Keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

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

Directions for Use

• Clean the skin thoroughly before applying this product.
• Cover the entire affected area with a thin layer one to three times daily.
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

INACTIVE INGREDIENTS

Water/Eau, SD Alcohol 40-B, Cyclodextrin, Polysorbate 20, Xanthan Gum, 4-Terpineol*, Triethanolamine, Galactoarabinan, Zinc Gluconate, Sodium Coco PG-Dimonium Chloride Phosphate, Leptospermum Scoparium Branch/Leaf Oil, Tocopheryl Acetate, Dipostassium Glycyrrhizate, Panthenol, Disodium EDTA, Cetearyl Ethylhexanoate, Butylene Glycol, Nasturtium Officinale Extract, Arctium Lappa Root Extract, Aloe Barbadensis Leaf Juice, Pyridoxine HCL, Retinyl Palmitate.

Principal Labeling

PARABEN FREE

salicylic acid
acne treatment

1fl. oz. 29mL
120applications

All Skin Types

This exclusive treatment formula gently and comprehensively controls the factors that contribute to the cycle of acne-troubled skin.
Features an exclusive blend of nourishing antioxidants and purifying botanicals to help normalize sebum, unclog pores, speed healing, and reduce
redness caused by acne. With continued use, skin will become visibly smoother, clearer, and shine free.

• Not tested on animals
• 100% free of
  occlusive oils

Shaklee
Dist. by/par
Shaklee Corporation
4747 Willow Road
Pleasanton, CA 94588 USA
Item #39075

Breakthrough patented
formula
Contains botanical
extracts:
- tea tree (Melaleuca
alternifolia) oil
- manuka
(Leptospermum
scoparium) oil
- licorice (Dipotassium
glycyrrhizate) extract
- burdock (Arctium
lappa) root extract
- watercress (Nasturtium
officinale) extract
- aloe vera (Aloe
barbadensis) leaf juice
Features antioxidant
vitamins A and E
Gentle enough to use
daily for maximum
acne control
100% fragrance and
paraben free
Allergy tested
Clinically formulated
Dermatologist tested

Do not store at
temperatures above 10O°F.
U.S. Palent: 6,403,110

Apply this exclusive facial formula to help keep skin blemish free, speed healing and reduce redness caused by acne. Gentle enough to use daily, this unique blend of botanicals and nourishing antioxidants effectively controls the factors that contribute to the cycle of acnetroubled
skin.

WARNINGS: For external use only. Keep out of eyes. “Keep out of reach of children. If excessive dryness or peeling occurs, reduce the application to once a day or every other day.

Directions: Apply one to three times daily after cleansing and toning. Allow to dry after application. Follow with the Enfuselle treatment or moisturizer for your skin type.

Package Labeling:

INGREDIENTS AND APPEARANCE

ENFUSELLE ACNE CLARIFYING 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59899-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
4-TERPINEOL, (+/-)- (UNII: L65MV77ZG6)
TROLAMINE (UNII: 9O3K93S3TK)
GALACTOARABINAN (UNII: SL4SX1O487)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
MANUKA OIL (UNII: M6QU9ZUH2X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PANTHENOL (UNII: WV9CM0O67Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NASTURTIUM OFFICINALE (UNII: YH89GMV676)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59899-002-01	1 in 1 CARTON	08/08/2013
1		29 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	08/08/2013

Labeler - Shaklee Corporation (020284076)