BABY ORAJEL NATURALS FOR TEETHING PAIN RELIEF (CALCAREA PHOSPHORICA, CHAMOMILLA, COFFEA CRUDA) GEL [CHURCH & DWIGHT CO., INC.]

BABY ORAJEL NATURALS FOR TEETHING PAIN RELIEF (CALCAREA PHOSPHORICA, CHAMOMILLA, COFFEA CRUDA) GEL [CHURCH & DWIGHT CO., INC.]
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NDC 10237-742-33, 10237-742-34
Set ID a7928b28-1f9b-4bcc-962a-bb01cb04d7d1
Category HUMAN OTC DRUG LABEL
Packager Church & Dwight Co., Inc.
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    Calcarea phosporica, 12x HPUS

    Chamomilla, 6x HPUS

    Coffea cruda, 6s HPUS

  • PURPOSE

    Purpose

    Supports dentition

    Irritability

    Restlessness

  • INDICATIONS & USAGE

    Use temporarily relieves the symptoms for simple restlessness and wakeful irritablility due to cutting teeth, for children under 4 months of age, consult with your physician or healthcare provider

  • WARNINGS

    Warnings

    Stop use and ask a physicianif symptoms persist for more than 7 days or if irritatino persists; inflammation, fever or infection develops

  • KEEP OUT OF REACH OF CHILDREN

    In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • wash hands
    • cut open tip of tube on score mark
    • use your fingertip or cotton applicator to apply a small, pea-size amount of Baby Orajel Naturals and spread over the gums
    • apply to the affected area up to 6 times daily or as directed by a physician or healthcare provide
    • for infants under 4 months of age, ask a physician or healthcare provider

    Other information
    Do not use if tube tip is cut prior to opening

  • INACTIVE INGREDIENT

    Inactive ingredients    glycerin, hydroxyethylcellulose, potassium sorbate, sodium benzoate, sorbic acid, water

  • QUESTIONS

    Questions or comments?  call us at 1-800-952-5080 M-F 9am-5pm or visit our webiste at www.orajelnaturals.com

  • PRINCIPAL DISPLAY PANEL

    Baby

    Orajel™

    Naturals

    for Teething Pain Relief

    Para el alivio del dolor de la denticion

    HOMEOPATHIC Homeopaticas

    Benzocaine Free Belladonna-Free

    Sin benzocaina Sin belladona

    Paraben-Free Dye-Free

    Sin parabeno Sin tintes

    Helps relieve teething discomfort

    NEW WT 0.33 OZ (9.4g) GEL

    BOJFC-32372-07

  • INGREDIENTS AND APPEARANCE
    BABY ORAJEL NATURALS  FOR TEETHING PAIN RELIEF
    calcarea phosphorica, chamomilla, coffea cruda gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-742
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION12 [hp_X]  in 1 g
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_X]  in 1 g
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBIC ACID (UNII: X045WJ989B)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-742-331 in 1 CARTON12/01/2012
    19.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10237-742-341 in 1 CARTON12/01/2012
    29.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/01/2012
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812manufacture(10237-742)

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