Label: BYE BYE BURNS- topical skin spray spray
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Contains inactivated NDC Code(s)
NDC Code(s): 64616-046-01, 64616-046-02 - Packager: Vitality Works, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated December 4, 2017
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- Bye Bye Burns
- Bye Bye Burns
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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
- Bye Bye Burns
- Bye Bye Burns
- Bye Bye Burns
- Bye Bye Burns
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INGREDIENTS AND APPEARANCE
BYE BYE BURNS
topical skin spray sprayProduct 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)