BYE BYE BURNS- topical skin spray spray 
Vitality Works, Inc

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

----------

Bye Bye Burns

Bye Bye Burns

Belladonna 6X

Cantharis 6X

Ranunculus bulbosa 6X

Urtica dioica 6X

Bye Bye Burns

Natural coconut oil, virgin olive oil, omega-3 shark liver oil, natural vitamin E.

Bye Bye Burns

Avoid contact with eyes. If symptoms persist for more than 7 days, discontinue use and contact your health care professional. In case of accidental overdose seek professional assistance or contact a poison control center immediately. All the ingredients are edible, but this product is not intended for internal use. Avoid spraying on clothing as the product will stain. In case of severe burns, or burns over large areas of the body, consult a doctor. Stop use and consult a doctor if the conditions persist or get worse.

Bye Bye Burns

Keep out of reach of children.

Bye Bye Burns

For the temporary relief of skin burns and pain from contact with hot surfaces, scalding, and from the sun. For the temporary reief of vesicular eruptions like blisters, and inflammation after a burn.

Bye Bye Burns

Adults or children over 2 years of age, apply to affected area up to 3-4 times daily. The harder you depress the sprayer cap, the more it will be directed in a stream rather than in a mist. Most of the oil will absorb directly into the skin within 15 minutes of application.

Bye Bye Burns

Belladonna  - burning of the skin from contact

Cantharis  - burns, scalds, and inflammation of the skin

Ranunculus bulbosa - blistering of the skin after a burn

Urtica dioica - burns, scalds, sunburns and itching from burns.

Bye Bye Burns

CartonLabel

BYE BYE BURNS 
topical skin spray spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64616-046
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [hp_X]  in 1 mL
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA6 [hp_X]  in 1 mL
RANUNCULUS BULBOSUS (UNII: AEQ8NXJ0MB) (RANUNCULUS BULBOSUS - UNII:AEQ8NXJ0MB) RANUNCULUS BULBOSUS6 [hp_X]  in 1 mL
URTICA DIOICA (UNII: 710FLW4U46) (URTICA DIOICA - UNII:710FLW4U46) URTICA DIOICA6 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
COCONUT OIL (UNII: Q9L0O73W7L)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
SHARK LIVER OIL (UNII: 4B24275HEU)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64616-046-021 in 1 CARTON08/23/2004
1NDC:64616-046-0159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/23/2004
Labeler - Vitality Works, Inc (137752817)
Registrant - Vitality Works, Inc. (137752817)
Establishment
NameAddressID/FEIBusiness Operations
Vitality Works, Inc.137752817manufacture(64616-046)

Revised: 12/2017
Document Id: 5f8ad9e0-ddbe-1c24-e053-2a91aa0ad070
Set id: 7c6c3a42-6dc9-400f-9bfd-59cdaf33ca41
Version: 3
Effective Time: 20171204
 
Vitality Works, Inc