Label: ENFUSELLE ACNE CLARIFYING- salicylic acid lotion
- NDC Code(s): 59899-002-01
- Packager: Shaklee Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 13, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Keep out of reach of children.
-
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.
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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.
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Principal Labeling
PARABEN FREE
salicylic acid
acne treatment1fl. oz. 29mL
120applicationsAll 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: 6,403,110Apply 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 lotionProduct 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 (129469263)