Label: INTENSIVE SKIN REPAIR- sambucus nigra flower calendula officinalis flower pinus lambertiana resin abies balsamea leaf oil salve

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated March 3, 2020

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

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    SAMBUCUS NIGRA (1X) HPUS (ELDERBERRY)

    ORG. CALENDULA (1X) HPUS (MARIGOLD)

    PINUS LAMBERTIANA (1X) HPUS (PINE RESIN)

    ABIES BALSAMEA (1X) HPUS (BALSAM FIR)

  • PURPOSE

    PROPERTIES

    ANTI-INFLAMMATORY

    SKIN HEALING REMEDY

    SKIN PROTECTANT

    SKIN PROTECTANT

  • INDICATIONS & USAGE

    USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH EXTREMELY DRY, DAMAGED, OR AGING SKIN.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: APPLY TO AFFECTED AREA MORNING AND/OR NIGHT.

  • INACTIVE INGREDIENT

    OTHER INGREDIENTS: ORGANIC BEESWAX, ORGANIC OLIVE OIL, ORGANIC ARGAN OIL, ORGANIC SEA BUCKTHORN OIL

  • WARNINGS

    WARNING: TEST FOR ALLERGY BY RUBBING A SMALL AMOUNT ON SKIN FIRST. DO NOT USE IF ALLERGIC TO OR HYPER-SENSITIVE TO ANY INGREDIENT IN THIS SALVE. IF CONDITION PERSISTS OR WORSENS CONSULT YOUR HEALTH CARE PROVIDER. (* = CERTIFIED ORGANIC INGREDIENTS)

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • QUESTIONS

    CUSTOMER SERVICE: 8:AM - 5:PM M - F 310-526-6108

  • PRINCIPAL DISPLAY PANEL

    intensive skin repair

  • INGREDIENTS AND APPEARANCE
    INTENSIVE SKIN REPAIR 
    sambucus nigra flower calendula officinalis flower pinus lambertiana resin abies balsamea leaf oil salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52810-204
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) (SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T) SAMBUCUS NIGRA FLOWER1 [hp_X]  in 100 mL
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER1 [hp_X]  in 100 mL
    PINUS LAMBERTIANA RESIN (UNII: 1D686UF007) (PINUS LAMBERTIANA RESIN - UNII:1D686UF007) PINUS LAMBERTIANA RESIN1 [hp_X]  in 100 mL
    ABIES BALSAMEA LEAF OIL (UNII: 2FGT9T2SQC) (ABIES BALSAMEA LEAF OIL - UNII:2FGT9T2SQC) ABIES BALSAMEA LEAF OIL1 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    HIPPOPHAE RHAMNOIDES WHOLE (UNII: YAA7TG74X6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52810-204-1130 mL in 1 JAR; Type 0: Not a Combination Product10/18/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/18/2012
    Labeler - PUREMEDY (003552251)
    Establishment
    NameAddressID/FEIBusiness Operations
    PUREMEDY003552251manufacture(52810-204)