Label: NEUTROGENA ADAPALENE 0.1% ACNE TREATMENT- adapalene gel
- NDC Code(s): 69968-0826-1
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 29, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
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Warnings
For external use only
Do not use
▪on damaged skin (cuts, abrasions, eczema, sunburn)
▪ if you are allergic to adapalene or any of the ingredients in 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 the 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
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Directions
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
- Other Information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 45 g Tube Carton
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INGREDIENTS AND APPEARANCE
NEUTROGENA ADAPALENE 0.1% ACNE TREATMENT
adapalene gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0826 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF) ADAPALENE 1 mg in 1 g Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) EDETATE DISODIUM (UNII: 7FLD91C86K) POLOXAMER 182 (UNII: JX0HIX6OAG) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0826-1 1 in 1 CARTON 12/04/2023 1 45 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090962 12/04/2023 Labeler - Johnson & Johnson Consumer Inc. (118772437)
