Label: ACNEEN- salicylic acid lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 43074-102-19, 43074-102-20 - Packager: Phillips Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 23, 2010
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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DRUG FACTS
Drug Facts
Active Ingredient Purpose
Salicylic acid (2%) Acne medication
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Uses
n Acne medication lotion. For the treatment of acne. Clears up most acne blemishes and allows skin to heal.
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Warnings
n For external use only
n When using this product, skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
n Keep away from children
n Avoid contact with eyes
n May be harmful if swallowed or inhaled
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Ask a physician
n If symptoms last for more than 7 days or clear up and recur within a few days.
n If the conditions do not improve.
n Before use on children under 2 years.
n Before use if you are allergic to any ingredients listed on this label.
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Directions
n Clean the skin thoroughly before applying this product.
n Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
n Each morning, cover the entire affected area with a thin layer of this product.
n Apply this product by rubbing it in. If any liquid remains on the skin (after a 20-second rub-in), you have applied too much product.
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Other information
Store at 40 to 100 degrees F. Net contents: 3 mL. This product contains no alcohol; no animal products.
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Inactive ingredients
Water, dimethyl sulfoxide, dipropylene glycol, ascorbic acid, sorbic acid, magnesium stearate, stearic acid.
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Questions and Side effects
Use of this product results in no known side effects when used according to directions. Phillips Company, 311 Chickasaw Street, Millerton, OK USA 74750; Tel. 580-746-2430
Email address: hp@valliant.net
- ACTIVE INGREDIENTS
- ASK DOCTOR
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DO NOT USE
n When using this product, skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
n Keep away from children
n Avoid contact with eyes
n May be harmful if swallowed or inhaled
- CHILDREN
- PURPOSE
- STOP USE
- WHEN USING
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WARNINGS
Warnings
n For external use only
n When using this product, skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
n Keep away from children
n Avoid contact with eyes
n May be harmful if swallowed or inhaled
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DOSAGE & ADMINISTRATION
Uses
n Acne medication lotion. For the treatment of acne. Clears up most acne blemishes and allows skin to heal.
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Directions
n Clean the skin thoroughly before applying this product.
n Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
n Each morning, cover the entire affected area with a thin layer of this product.
n Apply this product by rubbing it in. If any liquid remains on the skin (after a 20-second rub-in), you have applied too much product.
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USE
Uses
n Acne medication lotion. For the treatment of acne. Clears up most acne blemishes and allows skin to heal.
______________________________________
Directions
n Clean the skin thoroughly before applying this product.
n Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
n Each morning, cover the entire affected area with a thin layer of this product (ACNE22).
n Apply this product by rubbing it in. If any liquid remains on the skin (after a 20-second rub-in), you have applied too much product.
- INACTIVE INGREDIENTS
- Image of product
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INGREDIENTS AND APPEARANCE
ACNEEN
salicylic acid lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43074-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.02 mL in 1 mL Inactive Ingredients Ingredient Name Strength dimethyl sulfoxide (UNII: YOW8V9698H) ascorbic acid (UNII: PQ6CK8PD0R) dipropylene glycol (UNII: E107L85C40) water (UNII: 059QF0KO0R) sorbic acid (UNII: X045WJ989B) magnesium stearate (UNII: 70097M6I30) stearic acid (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43074-102-20 1 in 1 BOX 1 NDC:43074-102-19 3 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 12/30/2010 Labeler - Phillips Company (612368238) Establishment Name Address ID/FEI Business Operations Phillips Company 612368238 manufacture
