Label: PROACTIV MD KIT- md kit kit
- NDC Code(s): 11410-224-30, 11410-958-15
- Packager: Alchemee, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 12, 2024
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- Official Label (Printer Friendly)
- Adapalene Gel 0.1% - Drug Facts
- Adapalene Gel 0.1% - Active ingredient
- Adapalene Gel 0.1% - Purpose
- Adapalene Gel 0.1% - Use
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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
- irritation (redness, itching, dryness, burning) is more likely to occur:
- Adapalene Gel 0.1% - Keep out of reach of children
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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
- Adapalene Gel 0.1% - Inactive ingredients
- Questions or comments?
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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 & refreshedKit 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)
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INGREDIENTS AND APPEARANCE
PROACTIV MD KIT
md kit kitProduct 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)] liquidProduct 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 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 GREEN TEA LEAF (UNII: W2ZU1RY8B0) 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 COCONUT ACID (UNII: 40U37V505D) 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 gelProduct 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) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) WATER (UNII: 059QF0KO0R) EDETATE DISODIUM (UNII: 7FLD91C86K) POLOXAMER 182 (UNII: JX0HIX6OAG) PHENOXYETHANOL (UNII: HIE492ZZ3T) 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)] creamProduct 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 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 MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR GREEN TEA LEAF (UNII: W2ZU1RY8B0) 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 POLYSORBATE 60 (UNII: CAL22UVI4M) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) 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 POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR C12-15 ALKYL LACTATE (UNII: GC844VRD7E) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 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 Taro Pharmaceuticals Inc. 206263295 manufacture(11410-224) Establishment Name Address ID/FEI Business Operations kdc/one chatsworth, Inc. 118542196 manufacture(11410-224) Establishment Name Address ID/FEI Business Operations VEE PAK, LCC 874763303 manufacture(11410-224)