HEALING TREE CALMING ANTI-ITCH- hydrocortisone cream 
Renu Laboratories, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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HEALING TREE CALMING ANTI-ITCH CREAM

1 Percent Hydrocortisone

Anti-itch Anti-inflammatory

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

For external use only

Do not use

Stop use and ask a doctor if

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

If pregnant or breastfeeding 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

HEALING TREE

CALMING

ANTI-ITCH CREAM

NET WT. 59 ml (2.0 fl. oz.)

Directions

Other information

store between 20° to 25° C (68° to 77° F)

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? call 800-376-1293

Manufactured for

Healing Tree Essentials

Yamhill, OR 97148

healingtreenaturals.com

Multi-layer Label

Healing Tree Anti-Itch Cream

ANTI-ITCH CREAM LABEL

HEALING TREE CALMING ANTI-ITCH 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-804
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE0.59 mg  in 59 mL
Inactive Ingredients
Ingredient NameStrength
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)  
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)  
GOLDENSEAL (UNII: ZW3Z11D0JV)  
COMFREY (UNII: D05HXK6R3G)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TROLAMINE (UNII: 9O3K93S3TK)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76348-804-061 in 1 BOX05/26/2023
1NDC:76348-804-0559 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/26/2023
Labeler - Renu Laboratories, Inc. (945739449)
Establishment
NameAddressID/FEIBusiness Operations
Renu Laboratories, Inc.945739449manufacture(76348-804)

Revised: 5/2023
Document Id: fc8bcde9-26e9-a35f-e053-6394a90a3300
Set id: fc8bcde9-26e8-a35f-e053-6394a90a3300
Version: 1
Effective Time: 20230525
 
Renu Laboratories, Inc.