Bite, Bump and Rash Relief
DRUG FACTS:
e158a743-160f-446e-a0ea-a2ce566d866f
HUMAN OTC DRUG LABEL
May 21, 2025
Peaceful Mountain, Inc.
DUNS: 078430707
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Apis Mellifica, Astacus Fluviatilis, Belladonna, Calcarea Carbonica, Gelsemium Sempervirens, Mezereum, Rhus Tox
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (15)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL DISPLAY:
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)
INDICATIONS & USAGE SECTION
INDICATIONS:
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.
OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS:
(in gel): 1.43% of Apis Mellifica 12X, Astacus Fluviatilis 15X, Belladonna 12X, Calcarea Carbonica 12X, Gelsemium Sempervirens 15X, Mezereum 12X, Rhus Tox 12X.
OTC - PURPOSE SECTION
INDICATIONS:
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 SECTION
WARNINGS:
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF CHILDREN:
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
DIRECTIONS:
Apply at least 3 times daily over the affected area.
Children under 12 years of age: Consult a doctor.
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENTS:
Aloe Barbadensis Leaf Juice, Purified Water, Benzyl Alcohol (and) Ethylhexylglycerin (and) Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Sodium Hydroxide (Solution).
OTC - QUESTIONS SECTION
QUESTIONS:
Dist. by Peaceful Mountain, Inc.
Woodbine, IA 51579
888-303-3388
www.peacefulmountain.com