Healing Tree Calming Anti-itch Cream

Healing Tree Calming Anti-itch Cream
SPL v3
SPL
SPL Set ID fc8bcde9-26e8-a35f-e053-6394a90a3300
Route
TOPICAL
Published
Effective Date 2023-05-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (0.59 mg)
Inactive Ingredients
Goldenseal Comfrey Trolamine Potassium Sorbate Arnica Montana Flower Myrrh Oil Cetyl Alcohol Glyceryl Monostearate Melaleuca Alternifolia (tea Tree) Leaf Oil Peppermint Oil Jojoba Oil Peg-120 Methyl Glucose Dioleate Water Sodium Benzoate Avocado Oil Olive Oil Carbomer Homopolymer, Unspecified Type Glycerin Calendula Officinalis Flower Aloe Vera Leaf Polysorbate 20

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-05-26 Until 2025-11-05

Description

1 Percent Hydrocortisone


Medication Information

Warnings and Precautions

For external use only

Indications and 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

Dosage and 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
Description

1 Percent Hydrocortisone

Section 44425-7

Other information

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

Section 50565-1

KEEP OUT OF REACH OF CHILDREN

If swallowed get medical help or contact a Poison Control Center right away

Section 50566-9

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

Section 50569-3

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
Section 50570-1

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
Section 51727-6

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.

Section 53413-1

Questions? call 800-376-1293

Manufactured for

Healing Tree Essentials

Yamhill, OR 97148

healingtreenaturals.com

Section 53414-9

If pregnant or breastfeeding ask a health professional before use

Section 55105-1

Anti-itch Anti-inflammatory

Section 55106-9

1 Percent Hydrocortisone

Section 69718-5

HEALING TREE

CALMING

ANTI-ITCH CREAM

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

Multi Layer Label

Healing Tree Anti-Itch Cream


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

For external use only

Section 44425-7 (44425-7)

Other information

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

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

If swallowed get medical help or contact a Poison Control Center right away

Section 50566-9 (50566-9)

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

Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

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
Section 51727-6 (51727-6)

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.

Section 53413-1 (53413-1)

Questions? call 800-376-1293

Manufactured for

Healing Tree Essentials

Yamhill, OR 97148

healingtreenaturals.com

Section 53414-9 (53414-9)

If pregnant or breastfeeding ask a health professional before use

Section 55105-1 (55105-1)

Anti-itch Anti-inflammatory

Section 55106-9 (55106-9)

1 Percent Hydrocortisone

Section 69718-5 (69718-5)

HEALING TREE

CALMING

ANTI-ITCH CREAM

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

Multi Layer Label (Multi-layer Label)

Healing Tree Anti-Itch Cream


Advanced Ingredient Data


Raw Label Data

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