BYE BYE BURNS- topical skin spray spray

Bye Bye Burns by

Drug Labeling and Warnings

Bye Bye Burns by is a Homeopathic medication manufactured, distributed, or labeled by Vitality Works, Inc, Vitality Works, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

BYE BYE BURNS 
topical skin spray spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64616-046
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	6 [hp_X]  in 1 mL
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT)	LYTTA VESICATORIA	6 [hp_X]  in 1 mL
RANUNCULUS BULBOSUS (UNII: AEQ8NXJ0MB) (RANUNCULUS BULBOSUS - UNII:AEQ8NXJ0MB)	RANUNCULUS BULBOSUS	6 [hp_X]  in 1 mL
URTICA DIOICA (UNII: 710FLW4U46) (URTICA DIOICA - UNII:710FLW4U46)	URTICA DIOICA	6 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)
OLIVE OIL (UNII: 6UYK2W1W1E)
SHARK LIVER OIL (UNII: 4B24275HEU)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64616-046-02	1 in 1 CARTON	08/23/2004
1	NDC: 64616-046-01	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/23/2004

Labeler - Vitality Works, Inc (137752817)

Registrant - Vitality Works, Inc. (137752817)

Establishment
Name	Address	ID/FEI	Business Operations
Vitality Works, Inc.		137752817	manufacture(64616-046)