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Dr bump gel 16 - Medication Information

Product NDC Code 35192-053
Drug Name

Dr bump gel 16

Type Brand
Active Ingredients
Menthol 24 g/120g
Route TOPICAL
Dosage Form GEL
Application Number M017
Labeler Name CA-BOTANA INTERNATIONAL
Packages
Package NDC Code Description
35192-053-19 480 g in 1 bottle, pump (35192-053-19)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
OTC - ACTIVE INGREDIENT Menthol 5% Topical Analgesic

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.
Dosage & Admnistration External topical analgesic Topical massage gel no more than 4 times daily

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENTS Aesculus hippocastanum (Horse Chestnut), Aloe barbadensis miller, Aloe barbadensis miller (Aloe Vera), Amonium Acrylcydimethyltaurate/VPCcopolymer, Arnica montana (Arnica), Bromelain, Butylene Glycol, Capsicum annum ( Capsicum), Chamaemelum nobile (Chamomile), Ethyl alcohol, Eucalyptus globules (Eucaliptus) oil, FD&C Green # 3, Glucosamine Sulfate, Harpagophytum procumbens (Devil’s Claw), Melissa officinalis (Lemon Balm), Methyl Sulfonyl Methane (MSM), Polysorbate-60, Potassium Sorbate, Purified Water, Rosmarinus officinalis (Rosemary), Salix alba (Willow Bark), Edetic Acid, Tilia cordata (Linden), Xanthan Gum

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.
Indications & usage Apply generous amount of gel directly affected area massage into painful area until thoroughly absorbed into skin

Purpose

Information about the drug product’s indications for use.
OTC - PURPOSE SECTION Uses: for temporary relief of minor aches and pains of muscles and joints associated with. simple aches. back aches. arthritis.strains.bruises.sprains.

Spl product data elements

Usually a list of ingredients in a drug product.
Dr Bump gel 16 Menthol CHAMAEMELUM NOBILE FLOWER EUCALYPTUS OIL MENTHOL MENTHOL ARNICA MONTANA POTASSIUM SORBATE SALIX ALBA BARK HORSE CHESTNUT BROMELAINS BUTYLENE GLYCOL CAPSICUM TILIA CORDATA FLOWER GLUCOSAMINE SULFATE MELISSA OFFICINALIS DIMETHYL SULFONE AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER HARPAGOPHYTUM PROCUMBENS ROOT POLYSORBATE 60 WATER ROSEMARY EDETIC ACID ALCOHOL XANTHAN GUM ALOE VERA LEAF

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.
Label Dr Bump 16 Oz.jpg

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
OTC - ASK DOCTOR Stop use and ask a doctor if redness is present.irritation develops. conditions worsens or symtoms persist more than 7 days. symtoms clear up and occur again within a few days

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 Keep out of reach of children

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other Safety Information Protect this product from excessive heat and direct sun

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 Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

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