Label: CLEAR-N-SMOOTH- acne-pimple medication lotion
- NDC Code(s): 76445-0091-6
- Packager: Hawknad Manufacturing Industries, Inc.
- 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 January 10, 2023
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- Official Label (Printer Friendly)
- Indications for Use
- Purpose
- Dosage
- Keep Out of Reach of Children
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Warnings
For External Use Only
Flammable. Keep away from open flame or fire.
When Using this Product
- using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one acne medication should be used unless directed by a doctor.
- Apply to affected areas only. Do not use on broken skin or apply to large areas of the body.
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Instructions for Use
Cleanse the skin thoroughly before applying medication. Moisten a cotton ball with the lotion and cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, start with one application daily then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
- Inactive Ingredients
- Active Ingredient
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
CLEAR-N-SMOOTH
acne-pimple medication lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76445-0091 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.01 g in 1 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) 0.45 g in 1 g WATER (UNII: 059QF0KO0R) 0.49 g in 1 g PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.02 g in 1 g SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.01 g in 1 g SULISOBENZONE (UNII: 1W6L629B4K) 0.001 g in 1 g FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.00005 g in 1 g DIMETHICONOL (40 CST) (UNII: 343C7U75XW) 0.005 g in 1 g EDETATE DISODIUM (UNII: 7FLD91C86K) 0.001 g in 1 g LEVOMENTHOL (UNII: BZ1R15MTK7) 0.0005 g in 1 g Product Characteristics Color blue Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76445-0091-6 176 g in 1 BOTTLE; Type 0: Not a Combination Product 01/15/2001 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 01/02/1992 Labeler - Hawknad Manufacturing Industries, Inc. (618892426) Registrant - Hawknad Manufacturing Industries, Inc. (618892426) Establishment Name Address ID/FEI Business Operations EMS Acquisition Group 048602791 manufacture(76445-0091)
