Inactive Ingredient
CETOSTEARYL ALCOHOL, MINERAL OIL, PARAFFIN, WHITE PETROLATUM
Bm Calendula Ointment
FDA Label NDC 85816-6021
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bm Private Limited for the product Bm Calendula (NDC 85816-6021). 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 inactive ingredient, otc - active ingredient, contraindications, indications & usage, otc - purpose, dosage & administration, warnings, 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
Otc - Active Ingredient
Active ingredients (Ref. stand.)
Each 40gm contains
Aloe ver Ø 0.002 gm (HPUS)
Calendulla Ø 2.00 gm (HPUS)
Chamomilla Ø 0.04 gm (HPUS)
Contraindications
Care & contra-indications:
This is a homoeopathic product, no contra-indications are established.
Indications & Usage
Calendula
(Ointment) 40gm
Help support to relieve the symptoms of skin ailments
(For external use only)
Otc - Purpose
Calendula
(Ointment) 40gm
Help support to relieve the symptoms of skin ailments
(For external use only)
Dosage & Administration
For details please read the enclosed package (Product information leaflet).
Warnings
Precautions/storage:
Keep away from children and store at cool and dry place.
Otc - Keep Out Of Reach Of Children
Precautions/storage:
Keep away from children and store at cool and dry place.
Package Label.Principal Display Panel
entire package label
Calendulla (Calendulla)
* Please review the disclaimer below.
