Active Ingredients:
Calendula officinalis -12C HPUS,
Ranunculus bulbosus- 12C HPUS
H-cold Sores Formula Oil
FDA Label NDC 61077-127
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-cold Sores Formula (NDC 61077-127). 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
Purpose
| Calendula officinalis -12C HPUS (for herpes, healing agent),
Ranunculus bulbosus -12C HPUS (herpetic eruptions) The letters ‘HPUS’ indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States |
Inactive Ingredients:
| Essential Oil Blend (Cymbopogon martinii aerial parts,
Lavandula officinalis flower bud, Litsea cubeba seed, Melaleuca alternifolia leaf-branch, Pelargonium graveolens whole plant) |
Indications:
For the treatment of cold sore symptoms, such as fever blisters, soreness at blister site.
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 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 1042 N El Camino Real,
#B-426, Encinitas, CA 92024 USA
Principal Display Panel
Healing Natural Oils
H-Cold Sores
Formula
Homeopathic
For External Use Only
127
11ml (0.37 fl. oz)
amoils.com
H-cold Sores Formula Label (Hcoldsoreslabel)
* Please review the disclaimer below.
