FDA Label for Welly First Aid Kit Refill

View Indications, Usage & Precautions

Welly First Aid Kit Refill Product Label

The following document was submitted to the FDA by the labeler of this product Dongguan Shenglian Tins Products Co., Ltd.. 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.

Drug Facts




Active Ingredient



Hydrocortisone 1%

Lidocaine HCl 2.0%


Purpose



Anti-itch

TopicaI Pain Relief


Uses



For temporary relief of itching associated with minor skin irritations, inflammation, or rashes. Other uses of product should only be under the advice and supervision of a doctor.

For temporary pain relief associated with minor burns

First aid to help prevent infection in minor: ● Cuts ● Scrapes ● Burns


Warnings



For external use only.

For external use only.

For external use only.


Do Not Use



● in the eyes ● for treatment of diaper rash, consult a doctor.

  • in large quantities particularly, over raw or blistered areas
  • in the eyes. If this happens flush thoroughly with water
  • ● In the eyes ● Over large areas of the body ● If you are allergic to any of the ingredients


Stop Use, Ask A Doctor



● if condition worsens, or if symptoms persist for more than 7 days or clears up and occurs again within a few days ● with use of any other hydrocortisone product


Keep Out Of The Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center immediately.

If swallowed, get medical help or contact a Poison Control Center immediately.

If swallowed, get medical help or contact a Poison Control Center immediately.


Directions



● Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. ● Children under 2 years of age: Do not use and ask a doctor.

  • Adults and children 2 years of age and older:Apply to affected area not more than 3 to 4 times daily.
    • Children under 2 years of age:Do not use, consult a doctor.
    • ● Clean affected area and dry thoroughly. ● Apply small amount of product (amount equal to the surface area of the tip of a finger) on the area not more than 1-3 times daily ● May be covered by sterile bandage. ● Children under 2 years of age: Do not use, consult a doctor.


Other Information



● Store at 20° to 25°C (68° to 77°F).
● Do not use open or torn packets.

  • Store at 20° to 25°C to (68° to 77°F).
  • Do not use open or torn packets.
  • ● Store at 20° to 25°C (68° to 77°F).
    ● Do not use open or torn packets.


Inactive Ingredients



Ceteareth-20, Cetearyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Mineral Oil, Petrolatum, Phenoxyethanol, Water

Aloe Barbadensis leaf Juice , Aminomethyl Propanol, Carbomer, EthylhexyIglycerin, Maltodextrin, Menthol, Phenoxyethanol,Polyethylene Glycol, Purified Water, Tocopheryl Acetate.

Mineral Oil, White Petrolatum


Questions Or Comments?



Call 1-833-BE-WELLY (1-833-239-3559)

call 1-833-BE-WELLY (1-833-239-3559)

Call 1-833-BE-WELLY (1-833-239-3559)


Stop Use, Ask A Doctor If



  • condition worsens, or if symptoms persist for more than 7 days or clears up and occurs again within a few days

Active Ingredients (Each Gram Contains)



Bacitracin Zinc 400 units

Neomycin Sulfate 3.5 mg

Polymyxin B Sulfate 5,000 units


Purposes



First aid antibiotic


Ask A Doctor Before Use If You Have



deep or puncture wounds, animal bites or serious burns.


Stop Use And Ask A Doctor If



● Condition persists or gets worse. ● You need to use longer than 1 week. ● A rash or other allergic reaction develops.


Package Labeling:




Package Labeling:84956-011-01




Package Labeling:84956-017-01




Package Labeling:84956-007-01




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