Otc - Active Ingredient
1 Percent Hydrocortisone
Healing Tree Calming Anti-itch Cream
FDA Label NDC 76348-804
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Renu Laboratories, Llc for the product Healing Tree Calming Anti-itch (NDC 76348-804). 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, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Anti-itch Anti-inflammatory
Indications & Usage
Uses
For the temporary relief and aid in reducing redness, itching and irritation associated with eczema, psoriasis, poison oak and ivy, bug bites, rashes, minor burns, abrasions and blemishes
Warnings
For external use only
Otc - Do Not Use
Do not use
- for external genital, vaginal or anal itching
- with other hydrocortisone product unless consulted by a doctor
- in or near the eyes
- for diaper rash
Otc - Ask Doctor
Stop use and ask a doctor if
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
Otc - Stop Use
Stop use and ask a doctor if
condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding ask a health professional before use
Otc - 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
Statement Of Identity
HEALING TREE
CALMING
ANTI-ITCH CREAM
NET WT. 59 ml (2.0 fl. oz.)
Dosage & Administration
Directions
- adults and children 2 years of age and older: spray affected area not more than 3 to 4 times daily
- children under 2 years of age: do not use consult a doctor
- to apply to face, spray into palm of hand and gently apply
Storage And Handling
Other information
store between 20° to 25° C (68° to 77° F)
Inactive Ingredient
Aloe Barbadensis leaf juice (Aloe Vera), Arnica Montana Extract, Calendula Officinalis Extract (Calendula), Carbomer, Cetyl Alcohol,
Commiphora Myrrha Oil (Myrrh), Deionized Water, Glycerin, Glycerol Stearate,Hydrastis Canadensis Root Extract (Goldenseal),
Melaleuca Alternifolia Leaf Oil (Tea Tree), Mentha Piperita Oil (Peppermint), Olea Europaea Oil (Olive), PEG-120 Methyl Glucose
Dioleate, Persea Gratissima Oil (Avocado), Polysorbate 20, Potassium Sorbate, Simmondsia Chinensis Oil (Jojoba), Sodium
Benzoate, Symphytum Officinale Extract (Comfrey) Leaf, Triethanolamine.
Otc - Questions
Questions? call 800-376-1293
Manufactured for
Healing Tree Essentials
Yamhill, OR 97148
healingtreenaturals.com
Multi-Layer Label
Healing Tree Anti-Itch Cream
* Please review the disclaimer below.
