Anti Itch Balm
FDA Label NDC 57285-100

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Us Organic Group Corp for the product Anti Itch Balm (NDC 57285-100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, otc - ask doctor, otc - keep out of reach of children, warnings, instructions for use, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Peppermint Oil* ---------- 0.34%

*=Certified Organic Ingredient


Otc - Purpose

Anti-Itch

Indications & Usage

Temporarily relieves itching associated with Insect bites, Eczema, Minor burn, Sunburn, Minor skin irritations, minor cuts, scrapes, atopic dermatitis.

Otc - Ask Doctor

Ask a doctor if condition worsen

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Warnings

- For external use only

- Do not use in or near the eyes

- Keep out of reach of children

- Ask a doctor if condition worsen

Instructions For Use

- Apply affected area and rub rapidly for 10 seconds

- Adults and children 2 years of age and older

- Children under 2 years of age: ask a doctor

Dosage & Administration

Apply affected area and rub rapidly for 10 seconds.

Inactive Ingredient

Simmondsiachinensis (Organic Jojoba oil)*,Helianthus annuus (Organic Sunflower oil)*,Butyrospermumparkii (Organic Shea butter)*,Cera alba (Organic Bees wax)*,Calophylluminophyllum (Organic Tamanu oil)*,Oenotherabiennis (Organic Evening primerose oil)*,Rosemarinusoficinalis (Organic Rosemary) extract*,Vitamin E Oil,Lavandulaangustifolia (Organic Lavender essential oil)*,Melaleucaalternifolia (Organic Tea tree essential oil)*,Matricariarecutita (Organic Chamomile blue essential oil)*,Anthemisnobilis (Organic Chamomile roman essential oil)*,Boswelliacarterii (Organic Frankincense essential oil)*,Achilleamillefolium (Organic Yarrow blue essential oil)*
*= Certified Organic Ingredient

* Please review the disclaimer below.