Label: HEALING TREE CALMING ANTI-ITCH- hydrocortisone cream

  • NDC Code(s): 76348-804-05, 76348-804-06
  • Packager: Renu Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 May 25, 2023

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  • ACTIVE INGREDIENT

    1 Percent Hydrocortisone

  • PURPOSE

    Anti-itch Anti-inflammatory

  • INDICATIONS & USAGE

    Uses

    For the temporary relief and aid in reducing redness, itching and irritation associated with eczema, psoriasis, poison oak and ivy, bug bites, rashes, minor burns, abrasions and blemishes

  • WARNINGS

    For external use only

  • DO NOT USE

    Do not use

    • for external genital, vaginal or anal itching
    • with other hydrocortisone product unless consulted by a doctor
    • in or near the eyes
    • for diaper rash
  • ASK DOCTOR

    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
  • STOP USE

    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

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding ask a health professional before use

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

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

  • STATEMENT OF IDENTITY

    HEALING TREE

    CALMING

    ANTI-ITCH CREAM

    NET WT. 59 ml (2.0 fl. oz.)

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 2 years of age and older: spray affected area not more than 3 to 4 times daily
    • children under 2 years of age: do not use consult a doctor
    • to apply to face, spray into palm of hand and gently apply
  • STORAGE AND HANDLING

    Other information

    store between 20° to 25° C (68° to 77° F)

  • INACTIVE INGREDIENT

    Aloe Barbadensis leaf juice (Aloe Vera), Arnica Montana Extract, Calendula Officinalis Extract (Calendula), Carbomer, Cetyl Alcohol,

    Commiphora Myrrha Oil (Myrrh), Deionized Water, Glycerin, Glycerol Stearate,Hydrastis Canadensis Root Extract (Goldenseal),

    Melaleuca Alternifolia Leaf Oil (Tea Tree), Mentha Piperita Oil (Peppermint), Olea Europaea Oil (Olive), PEG-120 Methyl Glucose

    Dioleate, Persea Gratissima Oil (Avocado), Polysorbate 20, Potassium Sorbate, Simmondsia Chinensis Oil (Jojoba), Sodium

    Benzoate, Symphytum Officinale Extract (Comfrey) Leaf, Triethanolamine.

  • QUESTIONS

    Questions? call 800-376-1293

    Manufactured for

    Healing Tree Essentials

    Yamhill, OR 97148

    healingtreenaturals.com

  • Multi-layer Label

    Healing Tree Anti-Itch Cream

    ANTI-ITCH CREAM LABEL

  • INGREDIENTS AND APPEARANCE
    HEALING TREE CALMING ANTI-ITCH 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-804
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE0.59 mg  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    MYRRH OIL (UNII: H74221J5J4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    JOJOBA OIL (UNII: 724GKU717M)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    WATER (UNII: 059QF0KO0R)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GOLDENSEAL (UNII: ZW3Z11D0JV)  
    COMFREY (UNII: D05HXK6R3G)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-804-061 in 1 BOX05/26/2023
    1NDC:76348-804-0559 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/26/2023
    Labeler - Renu Laboratories, Inc. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    Renu Laboratories, Inc.945739449manufacture(76348-804)
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