Proactiv Md ®

Proactiv Md ®
SPL v5
SPL
SPL Set ID 0a9b3755-c0db-4282-e063-6394a90a0c08
Route
TOPICAL
Published
Effective Date 2017-08-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
ANDA Active Since 2023-11-16

Description

Drug Facts

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Drug Facts

Use
  • For the treatment of acne
Section 42229-5

Drug Facts

Section 50565-1

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

Section 53414-9

If pregnant or breast-feeding, ask a doctor before use.

Warnings

For external use only

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

Do Not Use
  • on damaged skin (cuts, abrasions, eczema, sunburn)
  • if you are allergic to adapalene or any of the ingredients in this product.
Questions?

1-800-950-4695

Active Ingredient

Adapalene 0.1% (retinoid)

read consumer information leaflet

Other Information
  • TAMPER EVIDENTl DONOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR VISIBLE.
  • store at 20° to 25°C (68°- 77°F) (see USP Controlled Room Temperature).
  • protect from freezing
Inactive Ingredients

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

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
Stop Use and Ask A Doctor If
  • you become pregnant, or are planning to become pregnant, while using the product
  • you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath)
  • irritation becomes severe
  • you see no improvement after 3 months of once daily use
Principal Display Panel 45 G Tube Box

proactivMD ®

ADAPALENE GEL 0.1%

ACNE TREATMENT

PARABEN-FREE

First FDA-Approved

Over-the-Counter

Topical Retinoid* for

Acne Treatment

Previously Available

Only By Prescription

Dermatologist

Developed and Tested

*Read carton and enclosed consumer

information leaflet before using

this product. Keep this carton and

consumer information leaflet.

They contain important information.

NET WT 1.6 OZ (45 g)


Structured Label Content

Use
  • For the treatment of acne
Section 42229-5 (42229-5)

Drug Facts

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 53414-9 (53414-9)

If pregnant or breast-feeding, ask a doctor before use.

Purpose

Acne treatment

Warnings

For external use only

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

Do Not Use (Do not use)
  • on damaged skin (cuts, abrasions, eczema, sunburn)
  • if you are allergic to adapalene or any of the ingredients in this product.
Questions?

1-800-950-4695

Active Ingredient (Active ingredient)

Adapalene 0.1% (retinoid)

read consumer information leaflet

Other Information (Other information)
  • TAMPER EVIDENTl DONOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR VISIBLE.
  • store at 20° to 25°C (68°- 77°F) (see USP Controlled Room Temperature).
  • protect from freezing
Inactive Ingredients (Inactive ingredients)

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

When Using This Product (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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you become pregnant, or are planning to become pregnant, while using the product
  • you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath)
  • irritation becomes severe
  • you see no improvement after 3 months of once daily use
Principal Display Panel 45 G Tube Box (PRINCIPAL DISPLAY PANEL - 45 g Tube Box)

proactivMD ®

ADAPALENE GEL 0.1%

ACNE TREATMENT

PARABEN-FREE

First FDA-Approved

Over-the-Counter

Topical Retinoid* for

Acne Treatment

Previously Available

Only By Prescription

Dermatologist

Developed and Tested

*Read carton and enclosed consumer

information leaflet before using

this product. Keep this carton and

consumer information leaflet.

They contain important information.

NET WT 1.6 OZ (45 g)


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Raw Label Data

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