Label: PRO CLEAR FOAM- salicylic acid acne treatment liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 79061-042-01 - Packager: RELUMINS LABS LLC
- 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 July 1, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
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Directions
- Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below
- clean the skin thoroughly before applying this product
- 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
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Package Labels - 2 fl oz (60 mL) - NDC 79061-042-01
Bottle Label
RELUMINS
PRO CLEAR FOAM
Advanced Botanical Formula with 2% Salicylic Acid
Complete Facial Care For Blemish-Prone Skin
Penetrates Deep • Promotes Clear Skin
PROFESSIONAL SKIN CARE
2 fl oz (60 ml)
EXP:
LOT:
Relumins Labs
USA
183 Locust Ave
West Long Branch, NJ 07764
www.relumins.com
Carton Label
RELUMINS
PRO CLEAR FOAM
Advanced Botanical Formula
Salicylic Acid Acne Treatment
Complete Facial Care For Blemish-Prone Skin
Penetrates Deep • Promotes Clear Skin
PROFESSIONAL SKIN CARE
2 fl oz (60 ml)
EXP:
LOT:
Relumins Labs
USA
183 Locust Ave
West Long Branch, NJ 07764
www.relumins.com
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INGREDIENTS AND APPEARANCE
PRO CLEAR FOAM
salicylic acid acne treatment liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79061-042 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCOLIC ACID (UNII: 0WT12SX38S) PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G) PEAR JUICE (UNII: F214DLA9BE) REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ) HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22) AZADIRACHTA INDICA LEAF (UNII: HKY915780T) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) SOYBEAN (UNII: L7HT8F1ZOD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79061-042-01 1 in 1 CARTON 05/21/2021 1 60 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 05/21/2021 Labeler - RELUMINS LABS LLC (081506626) Establishment Name Address ID/FEI Business Operations COSMESTHETIC LABS. CORP. 725862577 manufacture(79061-042)