BABY ORAJEL NATURALS TWIN PACK (ORAJEL NATURALS) GEL [CHURCH & DWIGHT CO., INC.]

BABY ORAJEL NATURALS TWIN PACK (ORAJEL NATURALS) GEL [CHURCH & DWIGHT CO., INC.]
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NDC 10237-757-18, 10237-757-19
Set ID 40f4cc70-674a-44ef-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Church & Dwight Co., Inc.
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    Daytime:

    Calcarea phosporica, 12x HPUS

    Chamomilla, 6x HPUS

    Coffea cruda, 6x HPUS

    Nightime:

    Calcarea phosporica, 12x HPUS

    Chamomilla, 6x HPUS

    Coffea cruda, 6s HPUS

    Passiflora incarnata (Passion Flower), 6x HPUS

  • PURPOSE

    Supports dentition

    Irratability

    Restlessness

  • INDICATIONS & USAGE

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

  • WARNINGS

    Stop use and ask a physician if 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

    Daytime:

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

    Nighttime:

    flavor, glycerin, hydroxyethylcellulose, potassium sorbate, sodium benzoate, sorbic acid, water

  • QUESTIONS

    Questions or comments call us at 800 952 5080 Monday through Friday 9 to 5 or visit our website at www orajel com

  • PRINCIPAL DISPLAY PANEL

    #1 Teething Brand

    recommended by Pediatricians

    Marca numero 1 recomendada

    por Pediatras para la denticion

    Baby

    ORAJEL™

    Naturals

    for Teething Pain Relief

    Para el alivio del dolor de la denticion

    2 gels

    Homeopathic Homeopaticas

    Daytime & Nighttime

    Twin Pack

    Paraben-Free Benzocaine-Free Belladonna-Free Dye-Free

    Sin parabeno Sin benzocaina Sin Belladona Sin tintes

    HELPS RELIEVE TEETHING DISCOMFORT Ayuda A Aliviar El Malestar De La Denticion

    2 TUBES NET WT 0.18 OZ (5.1g) EACH

    Horizontal Pack 00005

    BOJFC-00005-03H

    Vertical 00007

    _BOJFC-00007-03V

  • INGREDIENTS AND APPEARANCE
    BABY ORAJEL NATURALS TWIN PACK 
    orajel naturals gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-757
    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
    PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) (PASSIFLORA INCARNATA FLOWER - UNII:K8F3G29S6Z) PASSIFLORA INCARNATA FLOWER6 [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)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-757-181 in 1 CARTON01/01/2015
    15.1 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10237-757-191 in 1 CARTON01/01/2015
    25.1 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2015
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812manufacture(10237-757)

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