PROACTIV MD KIT- md kit kit

Proactiv MD Kit by

Drug Labeling and Warnings

Proactiv MD Kit by is a Otc medication manufactured, distributed, or labeled by Alchemee, LLC, kdc/one chatsworth, Inc., Sun Pharma Canada Inc., VEE PAK, LCC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Adapalene Gel 0.1% - Drug Facts

Drug Facts

Adapalene Gel 0.1% - Active ingredient

Adapalene Gel 0.1% (retinoid)

Adapalene Gel 0.1% - Purpose

Acne treatment

Adapalene Gel 0.1% - Use

for the treatment of acne

Adapalene Gel 0.1% - Warnings

For external use only

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% - 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

• irritation becomes severe.

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

Adapalene Gel 0.1% - Keep out of reach of children

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

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% - Other information

• Store at room temperature 68o – 77oF
• protect from freezing

Adapalene Gel 0.1% - Inactive ingredients

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

Questions or comments?  

1-800-950-4695

SPL UNCLASSIFIED SECTION

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.

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)

INGREDIENTS AND APPEARANCE

PROACTIV MD KIT 
md kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-224

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-224-30	1 in 1 BOX; Type 0: Not a Combination Product	05/08/2024

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	60 mL  in 100
Part 2	1 TUBE	15 g  in 100
Part 3	1 TUBE	30 mL  in 100

Part 1 of 3

PROACTIV MD ULTRA-GENTLE CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads) [skin care preparations (creams, lotions, powder, and sprays)] liquid

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	SODIUM CITRATE (UNII: 1Q73Q2JULR)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	COCO-GLUCOSIDE (UNII: ICS790225B)
INGR	GREEN TEA LEAF (UNII: W2ZU1RY8B0)
INGR	WATER (UNII: 059QF0KO0R)
INGR	DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)
INGR	ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S AT 1.0%) (UNII: 8Z5ZAL5H3V)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	COCONUT ACID (UNII: 40U37V505D)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	HELIOTROPINE BUTANE-2,3-DIOL ACETAL (UNII: 7Y4ZV19ZDP)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
INGR	ISOPROPYL ALCOHOL (UNII: ND2M416302)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		60 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
Cosmetic		07/12/2024

Part 2 of 3

PROACTIV MD ADAPALENE  ACNE TREATMENT
adapalene gel

Product Information
Item Code (Source)	NDC: 11410-958
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF)	ADAPALENE	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLOXAMER 182 (UNII: JX0HIX6OAG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-958-15	1 in 1 BOX
1		15 g in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215940	05/08/2024

Part 3 of 3

PROACTIV MD ULTRA-HYDRATING MOISTURIZER 
moisturizing [skin care preparations (creams, lotions, powder, and sprays)] cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	ETHYLHEXYL PALMITATE (UNII: 2865993309)
INGR	HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
INGR	LEVOMENOL (UNII: 24WE03BX2T)
INGR	GLYCOGEN (UNII: 309GSC92U1)
INGR	ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
INGR	PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)
INGR	MORUS ALBA ROOT (UNII: CST1G9BZGD)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	HYDROGENATED PALM/PALM KERNEL OIL PEG-6 ESTERS (UNII: 8EPU9MJ01K)
INGR	GREEN TEA LEAF (UNII: W2ZU1RY8B0)
INGR	POLYSORBATE 60 (UNII: CAL22UVI4M)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
INGR	GLYCOL STEARATE (UNII: 0324G66D0E)
INGR	KOJIC ACID (UNII: 6K23F1TT52)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	WATER (UNII: 059QF0KO0R)
INGR	POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)
INGR	GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
INGR	DOCUSATE SODIUM/SODIUM BENZOATE (UNII: 656HXR6YXN)
INGR	SQUALANE (UNII: GW89575KF9)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	HEXYLENE GLYCOL (UNII: KEH0A3F75J)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	C12-15 ALKYL LACTATE (UNII: GC844VRD7E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 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
Cosmetic		11/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	05/08/2024

Labeler - Alchemee, LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
kdc/one chatsworth, Inc.		118542196	manufacture(11410-224)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Pharma Canada Inc.		243339023	manufacture(11410-224)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LCC		874763303	manufacture(11410-224)