Label: ENVIRONMENTAL ADAPTATION HOT AND HUMID- aloe socotrina, bromium, carbo vegetabilis, carboneum sulphuratum, colchicum autumnale, elaterium, gelsemium sempervirens, hamamelis virginiana, hypothalamus, iodum, ipecacuanha, natrum sulphuricum, piper nigrum, thyroidinum liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated November 22, 2016

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Drug Facts​__________________________________________________________________________________________________________

    HPUS active ingredients: Aloe socotrina, Bromium, Carbo vegetabilis, Carboneum sulphuratum, Colchicum autumnale, Elaterium, Gelsemium sempervirens, Hamamelis virginiana, Hypothalamus, Iodum, Ipecacuanha, Natrum sulphuricum, Piper nigrum, Thyroidinum​. Equal volumes of each ingredient in 10X, 30X, 100X, 1LM, 2LM, 3LM and 5LM potencies.

  • INDICATIONS & USAGE

    Uses for symptomatic relief of warm and damp environments: drowsiness, fatigue, nausea, appetite loss, internal heat and external chill, inflamed mucus membranes, limb pain, headache.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

  • WARNINGS

    Warnings

    • Stop use and ask your doctor if symptoms persist or worsen.
    • If pregnant or breast-feeding, take only on advice of a healthcare professional.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
  • DOSAGE & ADMINISTRATION

    Directions

    • Initially, depress pump until primed.
    • Spray one dose directly into mouth.
    • Adults 12 and up: 3 sprays 3 times per day.
    • Children 2-12 years: 2 sprays 3 times per day.
    • Use additionally as needed, up to 6 times per day.
  • OTHER SAFETY INFORMATION

    Tamper resistant for your protection. Use only if safety seal is intact. This product has not been clinically tested.

  • PURPOSE

    Uses ​for symptomatic relief of warm and damp environments:

    • drowsiness
    • fatigue
    • nausea
    • appetite loss
    • internal heat and external chill
    • inflamed mucus membranes
    • limb pain
    • headache
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ENVIRONMENTAL ADAPTATION HOT AND HUMID 
    aloe socotrina, bromium, carbo vegetabilis, carboneum sulphuratum, colchicum autumnale, elaterium, gelsemium sempervirens, hamamelis virginiana, hypothalamus, iodum, ipecacuanha, natrum sulphuricum, piper nigrum, thyroidinum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-0285
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE10 [hp_X]  in 59 mL
    BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G) BROMINE10 [hp_X]  in 59 mL
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL10 [hp_X]  in 59 mL
    CARBON DISULFIDE (UNII: S54S8B99E8) (CARBON DISULFIDE - UNII:S54S8B99E8) CARBON DISULFIDE10 [hp_X]  in 59 mL
    COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6) COLCHICUM AUTUMNALE BULB10 [hp_X]  in 59 mL
    ECBALLIUM ELATERIUM FRUIT (UNII: 8P8HWT6ZWC) (ECBALLIUM ELATERIUM FRUIT - UNII:8P8HWT6ZWC) ECBALLIUM ELATERIUM FRUIT10 [hp_X]  in 59 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT10 [hp_X]  in 59 mL
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK10 [hp_X]  in 59 mL
    BOS TAURUS HYPOTHALAMUS (UNII: S6G2NLH4Y7) (BOS TAURUS HYPOTHALAMUS - UNII:S6G2NLH4Y7) BOS TAURUS HYPOTHALAMUS10 [hp_X]  in 59 mL
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE10 [hp_X]  in 59 mL
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC10 [hp_X]  in 59 mL
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE10 [hp_X]  in 59 mL
    GREEN PEPPERCORN (UNII: 6G53L8ESRK) (GREEN PEPPERCORN - UNII:6G53L8ESRK) GREEN PEPPERCORN10 [hp_X]  in 59 mL
    THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (THYROID, UNSPECIFIED - UNII:0B4FDL9I6P) THYROID, UNSPECIFIED10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-0285-259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/22/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/22/2016
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-0285)