Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Apotheca Company
844330915
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Apotheca Company
Peaceful Mountain, Inc.
Apotheca Company
844330915
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bite, Bump and Rash Relief
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
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.
DOSAGE & ADMINISTRATION SECTION
DIRECTIONS:
Apply at least 3 times daily over the affected area.
Children under 12 years of age: Consult a doctor.
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 - 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.
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.
OTC - QUESTIONS SECTION
QUESTIONS:
Dist. by Peaceful Mountain, Inc.
Woodbine, IA 51579
888-303-3388
www.peacefulmountain.com
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).