FDA.reportPublic FDA data

Environmental Adaptation Hot and Humid

Manufacturer
King Bio Inc.
Effective date
2016-11-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:08:20

Label at a glance#

ProductEnvironmental Adaptation Hot and Humid
Active ingredientALOE, BROMINE, ACTIVATED CHARCOAL, CARBON DISULFIDE, COLCHICUM AUTUMNALE BULB, ECBALLIUM ELATERIUM FRUIT, GELSEMIUM SEMPERVIRENS ROOT, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, BOS TAURUS HYPOTHALAMUS, IODINE, IPECAC, SODIUM SULFATE, GREEN PEPPERCORN, THYROID, UNSPECIFIED
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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 SECTION

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 SECTION

Inactive Ingredients:

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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

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.

OTC - PURPOSE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-0285-22020-01-31C16284748780-19d75b9d0-0988-f424-e053-dadaa90a57ceEnvironmental Adaptation Hot and Humid™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-0285-2Environmental Adaptation Hot and Humid59 mL in 1 BOTTLE, SPRAYLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-0285ENVIRONMENTAL 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 [KING BIO INC.]1Legacy NDC, 1 package rows20161122_1ecfc201-f535-401f-a1fa-db5efc330f0b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-028557955-0285-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOEV5VD430YW9ACTIB
BROMINESBV4XY874GACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
CARBON DISULFIDES54S8B99E8ACTIB
COLCHICUM AUTUMNALE BULB993QHL78E6ACTIB
ECBALLIUM ELATERIUM FRUIT8P8HWT6ZWCACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
BOS TAURUS HYPOTHALAMUSS6G2NLH4Y7ACTIB
IODINE9679TC07X4ACTIB
IPECAC62I3C8233LACTIB
SODIUM SULFATE0YPR65R21JACTIB
GREEN PEPPERCORN6G53L8ESRKACTIB
THYROID, UNSPECIFIED0B4FDL9I6PACTIB
WATER059QF0KO0RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
POTASSIUM SORBATE1VPU26JZZ4IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a1db02cd-8eae-40c2-b958-ea93dc4f13a91ecfc201-f535-401f-a1fa-db5efc330f0b2016-11-22WarningsExact identifier
spl id: a1db02cd-8eae-40c2-b958-ea93dc4f13a9
spl set id: 1ecfc201-f535-401f-a1fa-db5efc330f0b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.