enfuselle acne clarifying complex ​

enfuselle acne clarifying complex ​
SPL v10
SPL
SPL Set ID dd429a9b-5c2d-4310-8506-6487b02e3880
Route
topical
Published
Effective Date 2017-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (5 mg)
Inactive Ingredients
water xanthan gum 4-terpineol, (+/-)- trolamine galactoarabinan zinc gluconate manuka oil .alpha.-tocopherol acetate glycyrrhizinate dipotassium panthenol edetate disodium cetearyl ethylhexanoate butylene glycol nasturtium officinale arctium lappa root aloe vera leaf pyridoxine hydrochloride vitamin a palmitate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2013-08-08

Purpose

Acne treatment

Description

Salicylic Acid (0.5%)


Medication Information

Warnings
  • For external use only.
Uses

For the treatment of acne.

Purpose

Acne treatment

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.

Description

Salicylic Acid (0.5%)

Drug Facts



Active Ingredient

Salicylic Acid (0.5%)

Package Labeling:

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.
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.





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.

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

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.


Structured Label Content

Warnings
  • For external use only.
Uses

For the treatment of acne.

Purpose

Acne treatment

Inactive Ingredients (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.

Drug Facts



Active Ingredient

Salicylic Acid (0.5%)

Package Labeling:

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.
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.





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.

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

When Using This Product (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. (Keep out of reach of children.)

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


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