Label: H-BALM CONTROL EXTRA STRENGTH- calendula officinalis flowering top, echinacea, sodium chloride, and thuja occidentalis leafy twig solution/ drops
- NDC Code(s): 51393-6657-1, 51393-6657-2, 51393-6657-4
- Packager: Forces of Nature
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated April 24, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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ACTIVE INGREDIENT
Active Ingredients - *
- USDA Certified Organic
Echinacea Angustifolia* 10X - Relief from Skin Irritation Natrum Muriaticum 10X - Remedy for Oral Herpes, Painful Skin Eruptions Thuja Occidentalis* 10X - Relief for Skin Eruptions, Itching or Burning Pain Calendula Officinalis* 10X - Promotes Healthy Skin and Healing - Also Contains
- Indications
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Directions
Shake well before use. Apply 2-3 drops on a moistened swap and dab to problem area 3-4 times per day during an outbreak. For best result: Immediately and often at the very first signs of an outbreak or when you feel one coming on. Use of this product during prodrome (tingling some experience before an outbreak) may improve results. Apply to the soles of feet 3 times per day for systemic support. Wash hands after use. Avoid contact with eyes. For children under 2 years of age, consult a doctor before use.
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Warnings
Viral infections are contagious, and this product will not prevent the spread of the virus that causes herpes or any other virus. Some individuals may be sensitive to essential oils. Begin with a small drop to determine if the product causes any increased redness or irritation and discontinue use if it irritates your skin. For external use only. If accidental ingestion of more than several drops, and adverse reaction occurs, get medical help or contact a Poison Control Center. Do not apply to the eyes. If you are pregnant or breast-feeding, ask a health professional before use. Not for use on children under the age of 2 without physician direction.
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Tips For Use
H-Balm Control Extra Strength typically provides healing results in as little as 1-3 days. The healing time can be made longer or shorter depending on a few factors including:
- The strength of the individuals' immune system – the healthier the immune system the quicker your healing time will be.
- Your application schedule - H-Balm Control Extra Strength should be applied at least 3-4 times every day while the symptom exists.
H-Balm Control Extra Strength is a highly concentrated formula and only 1-2 drops per application is needed for maximum therapeutic affect. Apply directly to outbreak site with cotton swab or clean finger.
The first sign that the H-Balm Control Extra Strength is working is a slight tingling or cooling sensation at the site of the outbreak. Typically, the outbreak will begin to shrink within 1-2 days and it will continue to do so until completely healed.
Note: If you do not see results within 5 days, we recommend upgrading to H-Balm Control Extreme Strength.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 4 ml Bottle Label
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INGREDIENTS AND APPEARANCE
H-BALM CONTROL EXTRA STRENGTH
calendula officinalis flowering top, echinacea, sodium chloride, and thuja occidentalis leafy twig solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51393-6657 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 10 [hp_X] in 1000 mL ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED 10 [hp_X] in 1000 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 10 [hp_X] in 1000 mL THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG 10 [hp_X] in 1000 mL Inactive Ingredients Ingredient Name Strength Lavandin Oil (UNII: 9RES347CKG) Tea Tree Oil (UNII: VIF565UC2G) GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG) EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW) PALMAROSA OIL (UNII: 0J3G3O53ST) EUCALYPTUS OIL (UNII: 2R04ONI662) WHITE PINE OIL (UNII: HA5CX6676U) Product Characteristics Color YELLOW Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51393-6657-1 11 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 04/06/2011 2 NDC:51393-6657-2 33 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 04/06/2011 3 NDC:51393-6657-4 4 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 04/06/2011 Labeler - Forces of Nature (050169130)
