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Product NDC Code | 73492-711 | ||||
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Drug Name | Ultra strength pain relief balm |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | OINTMENT | ||||
RxCUI drug identifier | 1089847 | ||||
Application Number | M017 | ||||
Labeler Name | ALAINA HEALTHCARE PRIVATE LIMITED | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active Ingredients Camphor 11% Menthol 11%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions for adults and children over 12 years : rub well on the affected area. Repeat 3 to 4 times daily. for children 12 years of age or younger: consult a doctor before use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients cajuput oil, cassia oil, clove oil, dementholized mint oil, paraffin base.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, bruises, strains and sprains.
Purpose
Information about the drug product’s indications for use.Purpose Camphor-Topical Analgesic Menthol-Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Ultra Strength Pain Relief Balm CAMPHOR, MENTHOL CAJUPUT OIL CHINESE CINNAMON OIL CLOVE OIL PEPPERMINT OIL PARAFFIN MINERAL OIL CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) MENTHOL MENTHOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Ultra Strength Pain Relief Balm 0.63oz NDC- 73492-711-18-Label Ultra Strength Pain Relief Balm 0.63oz NDC - 73492-711-18-Carton Ultra strength pain relief balm 0.63oz NDC- 73492-711-18-Carton Ultra strength pain relief balm 0.63oz NDC- 73492-711-18-Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Manufactured By: Alaina Healthcare Private Limited Khasra No. 127-133, Baddi-Barotiwala Road, Baddi, HIMACHAL PRADESH 173205, India (IND). Distributed By: Walmart Inc., Bentonville, AR 72716. PRODUCT OF INDIA. * This product is not manufactured or distributed by Ferndale IP, Inc., Owner of the registered trademark RectiCare ® .
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information This product may cause allergic reaction on some individuals. Test on a small area before use.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call 1-888-287-1915.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only. When using this product Use only as directed. avoid contact with eye and mucous membranes. do not apply to wounds, damaged or irritated skin. do not bandage or cover with wrap or heating pad. do not use 1 hour prior to bathing or within 30 minutes after bathing. Stop use and ask a doctor if condition worsens. severe skin irritation occurs. pain persists for more than 7 days. pain clears up and then recurs a few days later. If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API