H-jock Itch Formula Oil
FDA Label NDC 61077-088

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Healing Natural Oils Llc for the product H-jock Itch Formula (NDC 61077-088). 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 active ingredients:, purpose, inactive ingredients:, indications:, directions:, warnings:, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Calendula
 officinalis
 - ­
12C
 HPUS
,

Thuja
 occidentalis
­ - 12C
 HPUS


Purpose

Calendula
 officinalis
  - ­
12C 
HPUS 
(healing 
agent),


Thuja
 occidentalis - 
­12C 
HPUS 
(for
 fungus)


The letters ‘HPUS’ indicate that the components in this product are officially
monographed in the Homoeopathic Pharmacopoeia of the United States


Inactive Ingredients:

Corylus
 avellana
 nut
 oil, 
Essential
 Oil 
Blend
 (Citrus 
bergamia

peel, 
Lavandula
 officinalis
 flower 
bud,

Melaleuca
 alternifolia 
leaf-­branch,

Pelargonium
 graveolens 
whole 
plant).

Indications:

For the temporary relief of jock itch symptoms such as itching, redness and irritation.

Directions:

Adults and Children 4 yrs and over: Wash hands before and after use.
Shake well and apply 1 or 2 drops to a cotton swab or your finger and apply directly to the affected area 3x per day.
Do not oversaturate or exceed dosage.

Warnings:

For external use only.

Perform skin test prior to initial use.



Otc - Pregnancy Or Breast Feeding


Do not use if pregnant or breastfeeding.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Other Safety Information

Keep away from eyes and mucous membranes. If swallowed get medical help
or contact a Poison Control Center right away.

Otc - Stop Use

Discontinue use if irritation occurs.

Otc - Ask Doctor

Consult a doctor if symptoms worsen after 7 days.

Description

Dist. by Healing Natural Oils 3830 Valley Ctr Dr, #705-526, San Diego, CA 92130, USA

Package Label.Principal Display Panel

Healing Natural Oils

H-Jock Itch
Formula

Homeopathic

For External Use Only

088

11ml (0.37 fl. oz)
amoils.com

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