FDA Label for Bacitraycin Max Pain Relief
View Indications, Usage & Precautions
Bacitraycin Max Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Randob Labs, Ltd. Dba Crossingwell Consumer Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient (each gram contains)
Bacitracin zinc 500 units
Pramoxine HCl 10mg
Otc - Purpose
Purpose
First Aid Antibiotic
External Analgesic
Indications & Usage
Uses
first aid to help prevent infection and for the temporary relief of pain in minor
- cuts
- scrapes
- burns
Warnings
Warnings
For external use only.
Otc - Do Not Use
Do not use
- if you are allergic to any of the ingredients
- in the eyes
- over large areas of the body
Otc - Ask Doctor
Ask a doctor before useif you have
- deep or puncture wounds
- animal bites
- serious burns
Otc - Stop Use
Stop use and ask a doctor if
- you need to use longer than 1 week
- symptoms persist for more than 1 week, or clear up and occur again within a few days
- the condition persists or gets worse
- redness, irritation, swelling, or pain persists or increases
- a rash or other allergic reaction develops
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding,
ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Dosage & Administration
Directions
- adults and children 2 years of age and orlder:
- clean the affected area
- apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
- children under 2 years of age: ask a doctor
Storage And Handling
Other information
- store at room temperature 20° to 25° C (68° to 77° F)
Inactive Ingredient
Inactive ingredients
aloe vera gel and petrolatum
Other
Distributed by:
CrossingWell consumer health
Box440, Cornwall, NY 12518
Package Label.Principal Display Panel
DERMATOLOGIST
PREFERRED INGREDIENT
First Aid Antibiotic
with soothing aloe
- Prevents Infection
- Minimizes Scarring
- Sting Free
Helps to
heal burns,
cuts &
scrapes
BACITRAYCIN PLUS®
Bacitracin Zinc 500 Units (First Aid Antibiotic)
Pramoxine HCl 10mg (External Analgesic)
MAX
Pain Relief
OINTMENT
NET WT. 1 OZ. (28g)
BACITRAYCIN PLUS®
Bacitracin Zinc 500 Units (First Aid Antibiotic)
Pramoxine HCl 10mg (External Analgesic)
MAX
Pain Relief
OINTMENT
Helps to
heal burns,
cuts &
scrapes
First Aid Antibiotic
with soothing aloe
Prevents Infection
Minimizes Scarring
Sting Free
NET WT. 1 OZ. (28g)
* Please review the disclaimer below.
