FDA.reportPublic FDA data

Bite, Bump and Rash Relief

Manufacturer
Peaceful Mountain, Inc. | Apotheca Company
Effective date
2025-05-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:38:51

Label at a glance#

ProductBite, Bump and Rash Relief
Active ingredientAPIS MELLIFERA, ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, DAPHNE MEZEREUM BARK, TOXICODENDRON PUBESCENS LEAF, ASTACUS ASTACUS, GELSEMIUM SEMPERVIRENS ROOT
Label structure9 sections

Dosage and administration

Apply at least 3 times daily over the affected area. Children under 12 years of age: Consult a doctor.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in gel): 1.43% of Apis Mellifica 12X, Astacus Fluviatilis 15X, Belladonna 12X, Calcarea Carbonica 12X, Gelsemium Sempervirens 15X, Mezereum 12X, Rhus Tox 12X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve itching, insect bites, poison ivy, rashes, eczema, hives, inflammation and irritated red skin.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

For external use only.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

When using this product • Do not get into eyes.

Stop use and ask a doctor if • Conditions worsens • Symptoms last more than 7 days

Do not use if safety seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Apply at least 3 times daily over the affected area.

Children under 12 years of age: Consult a doctor.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve itching, insect bites, poison ivy, rashes, eczema, hives, inflammation and irritated red skin.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Purified Water, Benzyl Alcohol (and) Ethylhexylglycerin (and) Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Sodium Hydroxide (Solution).

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

peaceful mountain

THE HEIGHT OF HEALTH

bite, bump and

rash relief

homeopathic

anti-itch gel

paraben-free

unscented • non-greasy

No menthol • no animal testing

Net wt. 2 oz. (57 g)

Bite, Bump and Rash ReliefBite, Bump and Rash Relief

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43846-0079-12024-06-13C16284748780-1ba0f9c33-2464-a910-e053-dadaa90a0b85DRUG FACTS:
43846-0079-12021-01-29C16284748780-1ba0f9c33-2464-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43846-0079BITE, BUMP AND RASH RELIEF (APIS MELLIFICA, ASTACUS FLUVIATILIS, BELLADONNA, CALCAREA CARBONICA, GELSEMIUM SEMPERVIRENS, MEZEREUM, RHUS TOX) GEL [PEACEFUL MOUNTAIN, INC.]3Legacy NDC20250523_e158a743-160f-446e-a0ea-a2ce566d866f.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43846-007943846-0079-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
APIS MELLIFERA7S82P3R43ZACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
DAPHNE MEZEREUM BARKX2N6E405GVACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
ASTACUS ASTACUSV0551986XQACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
WATER059QF0KO0RIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
BENZYL ALCOHOLLKG8494WBHIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TOCOPHEROLR0ZB2556P8IACT
SODIUM HYDROXIDE55X04QC32IIACT
ALOE VERA LEAFZY81Z83H0XIACT
EDETATE DISODIUM7FLD91C86KIACT

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
d4d7bd33-3ca5-4c69-b005-b41328b15c6fe158a743-160f-446e-a0ea-a2ce566d866f2025-05-21WarningsExact identifier
spl id: d4d7bd33-3ca5-4c69-b005-b41328b15c6f
spl set id: e158a743-160f-446e-a0ea-a2ce566d866f

Reported adverse events (FAERS/openFDA)#

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