FDA Label for 4385 First Aid Kit
View Indications, Usage & Precautions
- EYEWASH ACTIVE INGREDIENT
- EYEWASSH PURPOSE
- EYEWASH USES
- EYEWASH WARNINGS
- DO NOT USE
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN
- EYEASH DIRECTIONS
- EYEWASH INACTIVE INGREDIENTS
- EYEASH QUESTIONS
- ISOTONIC SOLUTION FOR IRRIGATION.
- DESCRIPTION NACL IRRIGATION
- CLINICAL PHARMACOLOGY NACL IRRIGANT
- INDICATION AND USAGE NACL IRRIGANT
- CONTRAINDICATIONS NACL IRRIGANT
- WARNINGS NACL IRRIGANT
- PRECAUTIONS NACL IRRIGANT
- LABORATORY TESTS
- DRUG INTERACTIONS
- CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
- PREGNANCY
- LABOR AND DELIVERY
- NURSING MOTHERS
- PEDIATRIC USE
- GERIATRIC USE
- ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- OTHER
- DIRECTIONS FOR USE OF PIC™ (PLASTIC IRRIGATION CONTAINER)
- ALCOHOL WIPE ACTIVE INGREDIENT
- ALCOHOL WIPE PURPOSE
- ALCOHOL WIPE USES
- ALCOHOL WIPE WARNINGS
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND CONSULT A DOCTOR IF
- KEEP OUT OF THE REACH OF CHILDREN
- ALCOHOL WIPE DIRECTIONS
- ALCOHOL WIPE OTHER INFORMATION
- ALCOHOL WIPE INACTIVE INGREDIENTS
- ALCOHOL WIPE QUESTIONS
- PVP WIPESACTIVE INGREDIENTS
- PVP WIPES PURPOSE
- PVP WIPES USES
- PVP WIPES WARNINGS
- KEEP OUT OF REACH OF CHILDREN.
- PVP WIPES DIRECTIONS
- PVP WIPES OTHER INFORMATION
- PVP WIPES INACTIVE INGREDIENTS
- PVP WIPES QUESTIONS
- PAWS ACTIVE INGREDIENT
- PAWS PURPOSE
- PAWS USES
- PAWS WARNINGS
- DO NOT USE IN THE EYES.
- PAWS DIRECTIONS
- PAWS INACTIVE INGREDIENTS
- PAWS QUESTIONS
- 4385 346100 KIT CONTENTS
- EYEWASH PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL 500 ML CONTAINER
- ALCOHOL WIPE PRINCIPAL DISPLAY PANEL
- PVP WIPES PRINCIPAL DISPLAY PANEL
- PAWS PRINCIPAL DISPLAY PANEL
- 4385 KIT LABEL 346100
4385 First Aid Kit Product Label
The following document was submitted to the FDA by the labeler of this product Honeywell Safety Products Usa, Inc.. 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.
Eyewash Active Ingredient
Sterile Water 99%
Eyewassh Purpose
Eyewash
Eyewash Uses
- for flushing the eye to remove loose foreign material, air pollutants or chlorinated water
Eyewash Warnings
For external use only
- Obtain immediate medical treatment for all open wounds in or near eyes.
- To avoid contamination, do not touch tip of container to any surface.
- Do not reuse.
- Once opened, discard.
Do Not Use
- if solution changes color or becomes cloudy
- if you have open wounds in or near the eyes, get medical help right away.
- in or near eyes
- over large areas of the body
Stop Use And Ask A Doctor If
- you experience eye pain
- changes in vision
- continued redness or irritation of the eye
- condition worsens or persists
- condition worsens or persists for more than 72 hours
- irritation and redness develops
- irritation or redness develop and persists for more than 72 hours
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
If swallowed, get medical help or contact a Poison Control Center right away
Eyeash Directions
- remove contacts before using
- twist top to remove
- flush the affected area as needed
- control rate of flow by pressure on the bottle
- if necessary, continue flushing with emergency eyewash or shower
Eyewash Inactive Ingredients
sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic
Eyeash Questions
Call 1-800-430-5490 Honeywell Safety Products USA, Inc. Smithfield, RI 02917
Isotonic Solution For Irrigation.
For Irrigation Only.
Not for Injection.
Description Nacl Irrigation
Each 100 mL contains:
Sodium Chloride USP 0.9 g; Water for Injection USP qs
pH adjusted with Hydrochloric Acid NF
pH: 5.0 (4.5–7.0) Calculated Osmolarity: 310 mOsmol/liter
Concentration of Electrolytes (mEq/liter): Sodium 154; Chloride 154
0.9% Sodium Chloride Irrigation USP is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents.
The formula of the active ingredient is:
Ingredient Molecular Formula Molecular Weight
Sodium Chloride USP NaCl 58.44
The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and, therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert.
The PIC™ Container is PVC-free and DEHP-free.
Ingredient Molecular Formula Molecular Weight
Sodium Chloride USP NaCl 58.44
The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and, therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert.
The PIC™ Container is PVC-free and DEHP-free.
Clinical Pharmacology Nacl Irrigant
0.9% Sodium Chloride Irrigation USP is utilized for a variety of clinical indications such as sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters, surgical drainage tubes, and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. It also serves as a diluent or vehicle for drugs used for irrigation or other pharmaceutical preparations.
0.9% Sodium Chloride Irrigation USP provides an isotonic saline irrigation identical in composition with 0.9% Sodium Chloride Injection USP (normal saline).
Physiological irrigation solutions are considered generally compatible with living tissues and organs.
Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid.
Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.
Indication And Usage Nacl Irrigant
0.9% Sodium Chloride Irrigation USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.
Contraindications Nacl Irrigant
0.9% Sodium Chloride Irrigation USP is not for injection by usual parenteral routes.
An electrolyte solution should not be used for irrigation during electrosurgical procedures.
Warnings Nacl Irrigant
FOR IRRIGATION ONLY. NOT FOR INJECTION.
Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, irrigation solutions must be regarded as systemic drugs. Absorption of large amounts can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.
The risk of dilutional states is inversely proportional to the electrolyte concentrations of the administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.
Do not warm above 150°F (66°C).
After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation.
Discard unused portion of irrigating solution since it contains no preservatives.
Precautions Nacl Irrigant
General
Use aseptic technique when preparing and administering sterile irrigation solutions.
Use only if solution is clear and container and seal are intact.
Do not use for irrigation that may result in absorption of large amounts of fluid into the blood.
Caution should be observed when the solution is used for continuous irrigation or allowed to "dwell" inside body cavities because of possible absorption into the blood stream and the production of circulatory overload.
When used for irrigation via appropriate irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient.
Laboratory Tests
Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance after prolonged irrigation, when fluid absorption is suspected, or whenever the condition of the patient warrants such evaluation.
Drug Interactions
Some additives may be incompatible. Consult with pharmacist.When introducing additives, use aseptic technique.Mix thoroughly.
Do not store.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Studies with 0.9% Sodium Chloride Irrigation USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
Pregnancy
Teratogenic Effects
Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Irrigation USP. It is also not known whether 0.9% Sodium Chloride Irrigation USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.9% Sodium Chloride Irrigation USP should be given to a pregnant woman only if clearly needed.
Labor And Delivery
Safety and effectiveness of 0.9% Sodium Chloride Irrigation USP during labor and delivery have not been established. Caution should be exercised, and the fluid balance, glucose and electrolyte concentrations, and acid-base balance, of both mother and fetus should be evaluated periodically or whenever warranted by the condition of the patient or fetus.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 0.9% Sodium Chloride Irrigation USP is administered to a nursing woman.
Pediatric Use
The safety and effectiveness of 0.9% Sodium Chloride Irrigation USP in pediatric patients have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.
Geriatric Use
Clinical studies of 0.9% Sodium Chloride Irrigation USP did not include a sufficient number of patients age 65 years and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.Frequent laboratory determinations and clinical evaluations are recommended to monitor changes in blood glucose, electrolyte concentrations, and renal function.
Adverse Reactions
Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes can be minimized when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection.
If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.
Overdosage
In the event of overhydration or solute overload, reevaluate the patient's condition, and institute appropriate corrective treatment. Intravasular volume overload may respond to hemodialysis. See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.
Dosage And Administration
As required for irrigation.
When used as a diluent, or vehicle for other drugs, the drug manufacturer's recommendations should be followed.
Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.
Solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.
How Supplied
0.9% Sodium Chloride Irrigation USP is supplied sterile and nonpyrogenic in PIC™ (Plastic Irrigation Container). The 1000 mL and 500 mL containers are packaged 16 per case, the 2000 mL containers are packaged 8 per case, and the 4000 mL containers are packaged 4 per case.
0.9% Sodium Chloride Irrigation USP
NDC Cat. No. REF SIZE
0264-2201-00 R5200-01 1000 mL
0264-2201-10 R5201-01 500 mL
0264-2201-50 R5205-01 2000 mL
0264-2201-70 R5207 ,,,,4000 mL
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.
Do not warm above 150°F (66°C).
Other
Rx only
Revised: March 2009
PIC is a trademark of B. Braun Medical Inc.
B. Braun Medical Inc.
Irvine, CA 92614-5895 USA
Made in USA
Y36-002-699
Directions For Use Of Pic™ (Plastic Irrigation Container)
Not for injection.
Aseptic technique is required.
Caution – Before use, perform the following checks:
(a) Read the label. Ensure solution is the one ordered and is within the expiration date.
(b) Invert container and inspect the solution in good light for cloudiness, haze, or particulate matter; check the
container for leakage or damage. Any container which is suspect should not be used.
Use only if solution is clear and container and seal are intact
Single unit container. Discard unused portion.
Outer Closure Removal – Grasp the container with one hand and turn the breakaway ring counterclockwise with the other hand until slight resistance is felt. Then, twisting the container in the opposite direction, turn the breakaway ring sharply until the entire outer cap is loose and can be lifted off.
Figure 1
Connect the administration set through the sterile set port according to set instructions or remove screw cap and pour.
[Fig 2]
Figure 2
Do not warm above 150°F (66°C) to assure minimal bottle distortion. Keep bottles upright.
Alcohol Wipe Active Ingredient
Isopropyl alcohol 70%
Alcohol Wipe Purpose
First aid antiseptic
Alcohol Wipe Uses
first aid to help prevent infection in minor cuts, scrapes, and burns
Alcohol Wipe Warnings
For external use only
Flammable, keep away from fire and flame
Ask A Doctor Before Use If You Have
- deep or puncture wounds
- animal bites
- serious burns
- deep or puncture wounds
- animal bites
- serious burns
When Using This Product
- do not use longer than 1 week unless directed by a doctor
Stop Use And Consult A Doctor If
- condition persists or gets worse
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control center right away
Alcohol Wipe Directions
- clean the affected area
- may be covered with a sterile bandage
- apply wipe to affeted are 1 to 3 times daily
- discard wipe after single use
Alcohol Wipe Other Information
- store at room temperature 15 o to 25 0 C (59 0 to 77 0 oF)
- do not use if packet is torn or opened
Alcohol Wipe Inactive Ingredients
water
Alcohol Wipe Questions
1-800-430-5490
Pvp Wipesactive Ingredients
Povidone-iodine 10%
(equivalent to 1% titratable iodine)
Pvp Wipes Purpose
First aid antiseptic
Pvp Wipes Uses
- first aid antiseptic to help prevent infection in minor cuts, scrapes and burns
Pvp Wipes Warnings
For external use only.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Pvp Wipes Directions
- clean the affected area
- apply1 to 3 times daily
- may be covered with a sterile bandage
- if bandaged, let dry first
- discard wipe after single use
Pvp Wipes Other Information
- do not use on individuals who are allergic or sensitive to iodine
- store at controlled temperature 59-86°F (15-30°C)
- do not use if pouch is open or torn
Pvp Wipes Inactive Ingredients
nonoxynol 9, water
Pvp Wipes Questions
1-800-430-5490
Paws Active Ingredient
Ethyl alcohol 66.5%
Paws Purpose
Antiseptic
Paws Uses
- for handwashing to decrease bacteria on skin whenever soap and water is not readily available
Paws Warnings
For external use only
Flammable: keep away from fire or flame
Do Not Use In The Eyes.
If this happens, rinse thoroughly with water.
Paws Directions
- wet hands and wrists thoroughly for 15 seconds and allow to air dry
- always reseal after use
- children under 6 years of age should be supervised when using this product
Paws Inactive Ingredients
aloe vera, fragrance, purified water, triethanolamine
Paws Questions
1-800-430-5490
4385 346100 Kit Contents
1 ALCOHOL PREP PADS 10P
1 PVP IODINE WIPES 10 PER
1 NITRILE GLOVES 2PR BBP
1 O/H TAPE ADHESIVE TRI-CUT
1 BK GZ 4.5"X4.1YD6PLY RL ST MSO
1 FIRST AID GUIDE ASHI
1 EMERGENCY SURVIVAL BLANKET
2 GAUZE CLEAN-WRAP BDGE N/S 2"
1 BLOODSTOPPER
2 ABD COMBINE PAD 5" X 9"
2 ABD PADS 8"X10" STERILE
1 SOD. CHLORIDE 0.9% 500ML EA
1 4OZ BFS EYEWASH TRILINGUAL BOTTLE
1 EMPTY BAG RED 8X8X6
1 LBL STOCK 6-3/8"X4"
1 LBL STOCK 4"X2-7/8"
1 LBL STOCK 3"x1-7/8"
1 POLY BAG, 19 X 24 (CLEAR)
1 BANDAGE PACK FOR KIT
1 ZIP LOCK BAG FOR KIT #3
1 SELF-ADH WRAP 3 X 5 YDS NORTH REV E
1 WATER-JEL BURN DRESSING 4 X 4
1 CORRUGATED 24PK 01-0810 RSC
1 TRI BNDG NON WOVEN 40"X40"X56"
1 COLD PACK UNIT 4"X6" BULK
1 CPR MSK,PAWS WPS,GLVS 1
Eyewash Principal Display Panel
Paws Principal Display Panel
4385 Kit Label 346100
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