Label: ACNE TREATMENT MAXIMUM STRENGTH- salicylic acid gel

  • NDC Code(s): 70631-358-01, 70631-358-02
  • Packager: Young Living Essential Oils, LC
  • 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 November 3, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredients

    Salicylic Acid 2%

    Purpose

    Acne Treatmen

  • Uses

      For the treatment of acne

    • Clears acne blemishes, acne pimples, and blackheads and allows skin to heal
    • Penetrates pores to reduce the number of acne blemishes
    • Helps prevent the developent of new acne blemishes, pimples and blackheads.
  • Warnings For external use only

    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, use only one topical acne medication at a time

    Keep out of reach of children.

    If swallowed, get medical help or contact Poison Control Center right away.

  • Directions

    • Clean the skin thuroughly before applying this product
    • Cover the entire affected area with a thin layer 1 to 3 times daily
    • Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 to 3 times daily if needed or as directed by a doctor.
    • If bothersome dryness of peeling occurs, reduce application to 1 time a day or every other day.
  • Other Information

    Store at room temperature (68° to 77°F)

  • Inactive Ingredients

    Water, Glycerin, Cetostearyl alcohol, Lactobacillus reuteri, Cetyl alcohol, Coco-caprylate, Coconut alkanes, Cetearyl olicate, Aloe vera leaf, Starch-potato, Sorbitan olivate, Citric acid Monohydrate, Sodium hydroxide, Xanthan gum, coco-caprylate/caprate, .Alpha.-tocopheryl acetate, Sunflower oil, Phylate sodium, Manuka oil, Frankincense oil, Rosemary oil, Tea tree Oil, Geranium oil, Lavender oil, Chamomile, Salix alba bark, Tocopherol

  • PRINCIPAL DISPLAY PANEL

    Acne Treatmentctn

  • INGREDIENTS AND APPEARANCE
    ACNE TREATMENT MAXIMUM STRENGTH 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70631-358
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    LACTOBACILLUS REUTERI (UNII: 9913I24QEE)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    WILLOW BARK (UNII: S883J9JDYX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HEXASODIUM PHYTATE (UNII: ZBX50UG81V)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MANUKA OIL (UNII: M6QU9ZUH2X)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70631-358-021 in 1 CARTON06/07/2018
    1NDC:70631-358-0114.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00606/07/2018
    Labeler - Young Living Essential Oils, LC (836136630)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!