H-Fissures Formula
H-Fissures Formula is an FDA drug label for the active ingredient CALENDULA OFFICINALIS, CHAMOMILLA manufactured by Healing Natural Oils LLC administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20171227.
- Generic name
- CALENDULA OFFICINALIS, CHAMOMILLA
- Manufacturer
- Healing Natural Oils LLC
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 61077-036
- Application
- N/A
- Label effective
- 20171227
Active ingredients
Indications & Usage
Indications: For the temporary relief of anal fissure symptoms such as burning, soreness and minor bleeding.
Dosage & Administration
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.
Contraindications
Not available.
Warnings
Warnings: For external use only. Perform skin test prior to initial use. If pregnant or breastfeeding consult a doctor before use. Keep out of reach of children. Keep away from eyes and mucous membranes. If swallowed get medical help or contact a Poison Control Center right away. Discontinue use if irritation occurs. Consult a doctor if symptoms worsen after 7 days.
Adverse Reactions
Not available.