FDA Label for Bite, Bump And Rash Relief

View Indications, Usage & Precautions

Bite, Bump And Rash Relief Product Label

The following document was submitted to the FDA by the labeler of this product Peaceful Mountain, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.


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.

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:



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:



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


Directions:



Apply at least 3 times daily over the affected area.

Children under 12 years of age: Consult a doctor.


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).


Questions:



Dist. by Peaceful Mountain, Inc.
Woodbine, IA 51579

888-303-3388
www.peacefulmountain.com


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)


* Please review the disclaimer below.