Proactiv Md Kit

Proactiv Md Kit
SPL v2
SPL
SPL Set ID 1d142dba-145c-fb33-e063-6394a90a88b6
Route
TOPICAL
Published
Effective Date 2022-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Adapalene (0.1 g)
Inactive Ingredients
Sodium Hydroxide Propylene Glycol Phenoxyethanol Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Water Edetate Disodium Poloxamer 182

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-08

Description

Drug Facts

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Drug Facts

Section 42229-5

Distributed by Alchemee LLC

Santa Monica, CA 90401

Made in the USA of Foreign

and Domestic Components

Questions? 1-800-950-4695 • proactiv.com



Proactiv is a registered trademark

of Taro Pharmaceuticals U.S.A., Inc.



Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50570-1

Do not use

  • on damaged skin (cuts, abrasions, eczema, sunburn)
  • if you're allergic to adapalene or any of the ingredients in this product
Adapalene Gel 0.1% Use

for the treatment of acne

Questions Or Comments?  

1-800-950-4695

Adapalene Gel 0.1% Purpose

Acne treatment

Stop Use and Ask A Doctor If
  • irritation becomes severe.
Adapalene Gel 0.1% Warnings

For external use only

Adapalene Gel 0.1% Directions

Adults and children 12 years of age and older:

  • use once daily
  • clean the skin gently and pat dry before applying the product
  • cover the entire affected area with a thin layer. For example, if your acne is on the face, apply the product to the entire face.
  • do not use more than one time a day. Applying more than directed will not provide faster or better results, but may worsen skin irritation.

Children under 12 years of age: ask a doctor

Adapalene Gel 0.1% Drug Facts

Drug Facts

Adapalene Gel 0.1% Active Ingredient

Adapalene Gel 0.1% (retinoid)

Adapalene Gel 0.1% Other Information
  • Store at room temperature 68o – 77oF
  • protect from freezing
Principal Display Panel Proactivmd Kit

proactiv®

ProactivMD

3-step acne treatment system

Featuring our prescription-strength retinoid

Step 1: Cleanse

Washes away debris & oil

Step 2: Treat

First FDA-approved over-the-counter topical retinoid* for acne treatment

Previously available only by prescription.

Dermatologist developed and tested

*Read carton an consumer leaflet information before using

Step 3: Hydrate

Keeps skin hydrated & refreshed

Kit Contains: Ultra-Gentle Cleaner 2 FL. OZ. (60 mL) Adapalene Gel 0.1% 0.5 FL. OZ. (15 g) Ultra-Hydrating Moisturizer 1 FL. OZ. (30 mL)

Adapalene Gel 0.1% Inactive Ingredients

carbomer, disodium EDTA, phenoxyethanol, poloxamer 182, propylene glycol, sodium hydroxide, water

Adapalene Gel 0.1% When Using This Product
  • limit sun exposure, including light from tanning beds, and use sunscreen when going outdoors
  • do not wax to remove hair in areas where the product has been applied
  • during the early weeks of use, your acne may appear to worsen before it improves (this is normal); continue using as directed, unless you get irritation that becomes severe
    • irritation (redness, itching, dryness, burning) is more likely to occur:
      • in the first few weeks of use
      • if using more than one topical acne medication at a time
      • but irritation usually lessens with continued use of this product
      • it may take up to 3 months of once daily use to see results
      • avoid product contact with eyes, lips, and mouth. If contact occurs, immediately flush the area with water.
      • wash hands after use
Adapalene Gel 0.1% Keep Out of Reach of Children

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


Structured Label Content

Section 42229-5 (42229-5)

Distributed by Alchemee LLC

Santa Monica, CA 90401

Made in the USA of Foreign

and Domestic Components

Questions? 1-800-950-4695 • proactiv.com



Proactiv is a registered trademark

of Taro Pharmaceuticals U.S.A., Inc.



Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50570-1 (50570-1)

Do not use

  • on damaged skin (cuts, abrasions, eczema, sunburn)
  • if you're allergic to adapalene or any of the ingredients in this product
Adapalene Gel 0.1% Use (Adapalene Gel 0.1% - Use)

for the treatment of acne

Questions Or Comments?   (Questions or comments?  )

1-800-950-4695

Adapalene Gel 0.1% Purpose (Adapalene Gel 0.1% - Purpose)

Acne treatment

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation becomes severe.
Adapalene Gel 0.1% Warnings (Adapalene Gel 0.1% - Warnings)

For external use only

Adapalene Gel 0.1% Directions (Adapalene Gel 0.1% - Directions)

Adults and children 12 years of age and older:

  • use once daily
  • clean the skin gently and pat dry before applying the product
  • cover the entire affected area with a thin layer. For example, if your acne is on the face, apply the product to the entire face.
  • do not use more than one time a day. Applying more than directed will not provide faster or better results, but may worsen skin irritation.

Children under 12 years of age: ask a doctor

Adapalene Gel 0.1% Drug Facts (Adapalene Gel 0.1% - Drug Facts)

Drug Facts

Adapalene Gel 0.1% Active Ingredient (Adapalene Gel 0.1% - Active ingredient)

Adapalene Gel 0.1% (retinoid)

Adapalene Gel 0.1% Other Information (Adapalene Gel 0.1% - Other information)
  • Store at room temperature 68o – 77oF
  • protect from freezing
Principal Display Panel Proactivmd Kit (PRINCIPAL DISPLAY PANEL - ProactivMD Kit)

proactiv®

ProactivMD

3-step acne treatment system

Featuring our prescription-strength retinoid

Step 1: Cleanse

Washes away debris & oil

Step 2: Treat

First FDA-approved over-the-counter topical retinoid* for acne treatment

Previously available only by prescription.

Dermatologist developed and tested

*Read carton an consumer leaflet information before using

Step 3: Hydrate

Keeps skin hydrated & refreshed

Kit Contains: Ultra-Gentle Cleaner 2 FL. OZ. (60 mL) Adapalene Gel 0.1% 0.5 FL. OZ. (15 g) Ultra-Hydrating Moisturizer 1 FL. OZ. (30 mL)

Adapalene Gel 0.1% Inactive Ingredients (Adapalene Gel 0.1% - Inactive ingredients)

carbomer, disodium EDTA, phenoxyethanol, poloxamer 182, propylene glycol, sodium hydroxide, water

Adapalene Gel 0.1% When Using This Product (Adapalene Gel 0.1% - When using this product)
  • limit sun exposure, including light from tanning beds, and use sunscreen when going outdoors
  • do not wax to remove hair in areas where the product has been applied
  • during the early weeks of use, your acne may appear to worsen before it improves (this is normal); continue using as directed, unless you get irritation that becomes severe
    • irritation (redness, itching, dryness, burning) is more likely to occur:
      • in the first few weeks of use
      • if using more than one topical acne medication at a time
      • but irritation usually lessens with continued use of this product
      • it may take up to 3 months of once daily use to see results
      • avoid product contact with eyes, lips, and mouth. If contact occurs, immediately flush the area with water.
      • wash hands after use
Adapalene Gel 0.1% Keep Out of Reach of Children (Adapalene Gel 0.1% - Keep out of reach of children)

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


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