EARTHS CARE HEMORRHOID RELIEF (WITCH HAZEL AND MENTHOL, UNSPECIFIED FORM) CREAM [DLC LABORATORIES, INC.]

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  • EARTHS CARE HEMORRHOID RELIEF (WITCH HAZEL AND MENTHOL, UNSPECIFIED FORM) CREAM [DLC LABORATORIES, INC.]

EARTHS CARE HEMORRHOID RELIEF (WITCH HAZEL AND MENTHOL, UNSPECIFIED FORM) CREAM [DLC LABORATORIES, INC.]
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NDC 24286-1570-1
Set ID e860d65b-126d-4d77-8003-9d1381849ab5
Category HUMAN OTC DRUG LABEL
Packager DLC Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART347
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Menthol USP 0.8%Analgesic
    Witch Hazel USP 10%Astringent
  • Uses

    • temporary relief of pain, itching, burning and discomfort associated with hemorrhoids
    • may provide a cooling sensation
    • can help distract from pain
    • aids in protecting anorectal areas
    • temporary relief of irritation
  • Warnings

    For external use only

    Allergy Alert

    • Certain persons can develop allergic reactions to ingredients in this product

    When using this product

    • do not exceed the recommended daily dosage unless directed by a doctor
    • do not put this product into the rectum by using fingers or any mechanical device or applicator

    Stop use and ask a doctor

    • if the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase
    • if bleeding occurs
    • if condition worsens or does not improve within 7 days

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

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

  • Directions

    Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or drying with a tissue or a soft cloth before applying cream. When first opening the tube, remove cap and lift foil safety seal from tube. Apply externally to the affected area up to 6 times daily.

    Children under 12 years of age: consult a doctor.

  • Inactive ingredients

    aloe vera (Aloe barbadensis) gel, calendula (Calendula officinalis) flower extract, chamomile (Matricaria recutita) flower extract, caprylic/capric triglyceride, cetyl alcohol, cetyl hydroxyethylcellulose, ethylhexylglycerin, glycerin, glyceryl stearate, heptyl undecylenate, horse chestnut (Aesculus hippocastanum) seed extract, lanolin, olive (Olea europaea) oil, phenoxyethanol, polyglyceryl-3 dicitrate/stearate, sweet almond (Prunus amygdalus dulcis) oil, purified water, shea (Butyrospermum parkii) butter, tocopherols

  • Questions

    1-888-602-6380

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Earth's Care Natural Products, Inc.
    Long Beach, California 90805 USA

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Box

    No Vasoconstrictors

    EARTH'S
    CARE®

    Hemorrhoid
    Relief Cream

    Dual-Action formula

    Relieves external
    discomfort

    with Witch Hazel and
    Menthol

    1%
    FOR THE
    PLANET℠
    MEMBER

    1 OZ. (28 g)

    PRINCIPAL DISPLAY PANEL - 28 g Tube Box
  • INGREDIENTS AND APPEARANCE
    EARTHS CARE HEMORRHOID RELIEF 
    witch hazel and menthol, unspecified form cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24286-1570
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Witch Hazel (UNII: 101I4J0U34) (Witch Hazel - UNII:101I4J0U34) Witch Hazel10 g  in 100 g
    Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form0.8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Lanolin (UNII: 7EV65EAW6H)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Cetyl Hydroxyethylcellulose (350000 MW) (UNII: T7SWE4S2TT)  
    Glycerin (UNII: PDC6A3C0OX)  
    Shea Butter (UNII: K49155WL9Y)  
    Almond Oil (UNII: 66YXD4DKO9)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Heptyl Undecylenate (UNII: W77QUB6GXO)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Olive Oil (UNII: 6UYK2W1W1E)  
    Tocopherol (UNII: R0ZB2556P8)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Horse Chestnut (UNII: 3C18L6RJAZ)  
    Calendula Officinalis Flower (UNII: P0M7O4Y7YD)  
    Chamaemelum Nobile Flower (UNII: O2T154T6OG)  
    Product Characteristics
    ColorWHITE (Off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24286-1570-11 in 1 BOX06/01/2017
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34706/01/2017
    Labeler - DLC Laboratories, Inc. (093351930)
    Establishment
    NameAddressID/FEIBusiness Operations
    DLC Laboratories, Inc.093351930MANUFACTURE(24286-1570) , LABEL(24286-1570)
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