Label: SKINLYCIOUS CLEAR SKIN ESSENTIALS STARTER KIT- salicylic acid kit
- NDC Code(s): 81574-001-03, 81574-003-01
- Packager: Skinlycious Pte Ltd
- 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 17, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
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Warnings
For External Use Only
Do not use if you
• are pregnant
• are a child under 3 years of age
• are allergic to salicylatesWhen 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.
• Avoid unnecessary sun exposure and use a sunscreen.
• Avoid contact with the eyes, lips and mouth.
• First time users may experience tingling sensation and visible peeling. After frequent usage, tingling and peeling will likely reduce.Stop use and ask a doctor if
• Irritation becomes severe - Keep out of reach of children
- Questions or Comments
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Direction
• Cleanse the skin thoroughly before applying this product
• For treatment of acne, wet cotton bud or pad with solution and cover the entire affected area with a thin layer one to three times daily. Suitable for both facial and body acne.
• 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.
• Complement this with other Skinlycious products to reduce the likelihood of skin dryness.
• For full face exfoliant, wet cotton pad with a solution and apply a thin layer in the evening only over the entire face. No need to rinse off. Once skin condition improves, reduce frequency to no more than 3-5 times a week in the evening only. - Inactive Ingredients
- Product labels
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INGREDIENTS AND APPEARANCE
SKINLYCIOUS CLEAR SKIN ESSENTIALS STARTER KIT
salicylic acid kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81574-003 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81574-003-01 1 in 1 KIT 07/01/2021 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, GLASS 8 mL Part 2 1 Part 3 1 Part 4 1 Part 1 of 4 SKINLYCIOUS GLOW EXFOLIANT
salicylic acid liquidProduct Information Item Code (Source) NDC:81574-001 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 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) MANDELIC ACID (UNII: NH496X0UJX) GLYCERIN (UNII: PDC6A3C0OX) PURSLANE (UNII: M6S840WXG5) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81574-001-03 8 mL in 1 BOTTLE, GLASS; 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 Part 2 of 4 CALMING CLEANSER
other skin care preparationsProduct Information Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic Part 3 of 4 HYDRATING SERUM
other skin care preparationsProduct Information Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic Part 4 of 4 CLARIFYING SERUM
other skin care preparationsProduct Information Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 07/01/2021 Labeler - Skinlycious Pte Ltd (595402258)
