FDA Label for Welly Excursion First Aid Kit
View Indications, Usage & Precautions
- 1% HYDROCORTISONE CREAM
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- OTHER
- DIRECTIONS
- INACTIVE INGREDIENTS
- TRIPLE ANTIBIOTIC OINTMENT
- ACTIVE INGREDIENT (IN EACH GRAM)
- OTC - KEEP OUT OF REACH OF CHILDREN
- PAIN RELIEF AND FEVER REDUCER
- ACTIVE INGREDIENT (IN EACH BROWN TABLET)
- OTHER INFORMATION
- QUESTIONS OR COMMENTS?
- EXCURSION FIRST AID KIT
- PACKAGING
Welly Excursion First Aid Kit Product Label
The following document was submitted to the FDA by the labeler of this product Welly Health Pbc. 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.
1% Hydrocortisone Cream
Drug Facts
Active Ingredient
Hydrocortisone 1.0%
Purpose
Anti-itch
First Aid Antibiotics
Pain reliever/fever reducer
Uses
- For temporary relief of itching associated with minor skin irritations, inflammation, or rashes.
- Other uses of product should be only under the advice and supervision of a doctor.
- temporarily relieves minor aches and pains due to:
- muscular aches
- backache
- toothache
- menstrual cramps
- headache
- the common cold
- minor pain of arthritis
- temporarily reduces fever
First aid to help prevent infection in minor cuts, scrapes and burns
Warnings
For external use only
Do not use
- in eyes
- for treatment of diaper rash
- for feminine itching
- if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
- with use of other hydrocortisone products
- internally
- in eyes
- over large areas of the body or on puncture wounds, animal bites or serious burns
- for more than 1 week unless directed by a doctor
- if you are allergic to any of the ingredients
- a rash or allergic reactions develops
- condition worsens or persists
- shock
- facial swelling
- asthma (wheezing)
- rash
- skin reddening
- blisters
- hives
- take more or for a longer time than directed
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have had stomach ulcers or bleeding problems
- have 3 or more alcoholic drinks every day while using this product
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn.
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
- you are taking a diuretic
- you have problems or serious side effects from taking pain relievers or fever reducers
- under a doctor’s care for any serious condition
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- taking any other drug
- take with food or milk if stomach upset occurs
- you experience any of the following signs of stomach bleeding.
- Feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
- you have symptoms of heart problems or stroke:
- chest pain
- slurred speech
- leg swelling
- trouble breathing
- weakness in one part or side of body
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
Stop use, ask a doctor
For external use only
Do not use
Stop use and ask a doctor if
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Do not use
Ask a doctor before use if
Ask a doctor or pharmacist before use if you are
When using this product
Stop use and ask a doctor if
If pregnant or breastfeeding,
ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Other
Keep out of reach of children. If ingested, contact a Poison Control Center right away
Directions
- apply to affected area not more than 3 to 4 times daily
- children under 2: ask a doctor
- clean affected area
- apply a small amount 1 to 3 times daily
- may cover with a sterile bandage
- do not take more than directed
- the smallest effective dose should be used
- adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
- If pain or fever does not respond to 1 tablet, 2 tablets may be used
- do not exceed 6 tablets in 24 hours, unless directed by a doctor
- children under 12 years: ask a doctor
Inactive Ingredients
emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax
petrolatum
carnauba wax, colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide
Triple Antibiotic Ointment
Drug Facts
Active Ingredient (In Each Gram)
Bacitracin zinc 400 units
Neomycin sulfate (3.5mg Neomycin)
Polymyxin B sulfate 5000 units
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If ingested, contact a Poison Control Center right away.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Pain Relief And Fever Reducer
Drug Facts
Active Ingredient (In Each Brown Tablet)
Ibuprofen USP, 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Other Information
- TAMPER EVIDENT: DO NO USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store between 20°-25°C (68°-77°F)
- avoid excessive heat 40°C (104°F)
- see label for expiration date and lot number
- use by expiration date on package
Questions Or Comments?
1-833-BE-WELLY
Excursion First Aid Kit
EXTRA LARGE FIRST AID KIT TO COVER ANY BUMP, BRUISE OR SCRAPE.
Everything you need (and more) for when the unbeaten path gets the best of you.
Flexible fabric bandages that can move with your every move.
Durable metal case keeps it all together.
Cleansing wipes, tape and ibuprofen to help you get back out there.
Triple Antibiotic ointment helps prevent infection.
KIT INCLUDES
72 COUNT - STANDARD FABRIC BANDAGES
54 COUNT - SMALL FABRIC BANDAGES
6 COUNT - LARGE BANDAGES (3"x4")
18 COUNT - WATERPROOF BANDAGES
1 COUNT - ROLL OF TAPE
8 COUNT - NON STICK PADS
10 COUNT - CLEANSING WIPES
10 COUNT - BUTTERFLY STRIPS
10 COUNT - TRIPLE ANTIBIOTIC PACKETS
10 COUNT - HYDROCORTISONE PACKETS
1 VIAL - IBUPROFEN
Manufactured for: Welly Health PBC
Minneapolis, MN 55402
1-833-BE-WELLY
WellyTM www.GetWelly.com
Products of USA and China with globally sourced materials
Product not made with natural rubber latex
Sterile unless individual wrapper opened or damaged.
Patent Pending
Packaging
* Please review the disclaimer below.