EARTHS CARE ANTI-ITCH (CAMPHOR (NATURAL), MENTHOL) CREAM [DLC LABORATORIES, INC.]

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EARTHS CARE ANTI-ITCH (CAMPHOR (NATURAL), MENTHOL) CREAM [DLC LABORATORIES, INC.]
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NDC 24286-1558-2
Set ID d1eabb5f-7086-4ff0-a398-3703c9ecd441
Category HUMAN OTC DRUG LABEL
Packager DLC Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Camphor 0.5%External analgesic
    Menthol 1%External analgesic
  • Uses

    for the temporary relief of pain and itching associated with minor skin irritations such as poison ivy/oak/sumac, sunburn, insect bites, and minor cuts and scrapes

  • Warnings

    For external use only

    When using this product

    • avoid contact with the eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few 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 and children 2 years of age and older:

    • apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.
  • Inactive ingredients

    beeswax, Butyrospermum parkii (shea) butter, cetearyl glucoside, cetyl alcohol, citric acid, glycerin, glyceryl stearate, heptyl undecylenate, hydrogenated castor oil, Oryza sativa (rice) bran extract, phenoxyethanol, potassium sorbate, Prunus amygdalus dulcis (sweet almond) oil, purified water, sodium stearoyl glutamate, sodium stearoyl lactylate, stearic acid, xanthan gum

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 68 g Tube Box

    Steroid-Free

    EARTH'S
    CARE™

    PARABEN
    • FREE •

    Anti-Itch
    Cream

    Natural Camphor & Menthol

    Proven itch relief for:

    Insect Bites •

    Poison Ivy/Oak/Sumac •

    Sunburn •

    with Shea Butter and Almond Oil

    1%
    FOR THE
    PLANET
    MEMBER

    2.4 OZ. (68 g)

    Principal Display Panel - 68 g Tube Box
  • INGREDIENTS AND APPEARANCE
    EARTHS CARE ANTI-ITCH 
    camphor (natural), menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24286-1558
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL).5 g  in 100 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    RICE BRAN (UNII: R60QEP13IC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24286-1558-21 in 1 BOX10/30/2013
    168 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:24286-1558-11 in 1 BOX05/01/2015
    228 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:24286-1558-32.8 g in 1 POUCH; Type 0: Not a Combination Product05/01/2015
    4NDC:24286-1558-46 g in 1 JAR; Type 0: Not a Combination Product05/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34810/30/2013
    Labeler - DLC Laboratories, Inc. (093351930)
    Establishment
    NameAddressID/FEIBusiness Operations
    DLC Laboratories, Inc.093351930MANUFACTURE(24286-1558) , LABEL(24286-1558)
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