HEALING TREE CALMING ANTI-ITCH- hydrocortisone cream

HEALING TREE CALMING ANTI-ITCH by

Drug Labeling and Warnings

HEALING TREE CALMING ANTI-ITCH by is a Otc medication manufactured, distributed, or labeled by Renu Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

1 Percent Hydrocortisone

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

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

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

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

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding ask a health professional before use

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.

QUESTIONS

Questions? call 800-376-1293

Manufactured for

Healing Tree Essentials

Yamhill, OR 97148

healingtreenaturals.com

Multi-layer Label

Healing Tree Anti-Itch Cream

INGREDIENTS AND APPEARANCE

HEALING TREE CALMING ANTI-ITCH 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-804
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	0.59 mg  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
GOLDENSEAL (UNII: ZW3Z11D0JV)
COMFREY (UNII: D05HXK6R3G)
TROLAMINE (UNII: 9O3K93S3TK)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
MYRRH OIL (UNII: H74221J5J4)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
PEPPERMINT OIL (UNII: AV092KU4JH)
JOJOBA OIL (UNII: 724GKU717M)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
AVOCADO OIL (UNII: 6VNO72PFC1)
OLIVE OIL (UNII: 6UYK2W1W1E)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYSORBATE 20 (UNII: 7T1F30V5YH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-804-06	1 in 1 BOX	05/26/2023
1	NDC: 76348-804-05	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/26/2023

Labeler - Renu Laboratories, LLC (119451815)

Establishment
Name	Address	ID/FEI	Business Operations
Renu Laboratories, LLC		119451815	manufacture(76348-804)