Label: DOCTOR HOYS NATURAL ARNICA BOOST- hpus arnica montana cream
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Contains inactivated NDC Code(s)
NDC Code(s): 10842-203-01, 10842-203-02, 10842-203-03, 10842-203-04, view more10842-203-06, 10842-203-08 - Packager: DOCTOR HOY'S, LLC
- Category: HUMAN OTC DRUG LABEL
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 5, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
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- Official Label (Printer Friendly)
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WARNINGS
Warnings: for external use only, avoid contact with eyes, Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center immediately, if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician, Pregnancy-breast feeding warning: if pregnant or breast feeding, ask a health professional before use, do not bandage tightly
- ACTIVE INGREDIENT
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INDICATIONS & USAGE
Directions: Use by itself or with DOCTOR HOY'S Natural Pain Relief Gel. For adults and children 2 years and older. "Children under 2 years of age: consult a doctor." For best results, apply generously to affected and surrounding areas. Repeat as needed.
Uses: for the temporary relief of minor aches and pains of muscles and joints due to: , inflammation, arthritis, sprains, strains, bruises
- PURPOSE
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KEEP OUT OF REACH OF CHILDREN
Warnings: for external use only, avoid contact with eyes, Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center immediately, if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician, Pregnancy-breast feeding warning: if pregnant or breast feeding, ask a health professional before use, do not bandage tightly
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DOCTOR HOYS NATURAL ARNICA BOOST
hpus arnica montana creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10842-203 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA WHOLE - UNII:O80TY208ZW) ARNICA MONTANA 5 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) CHAMOMILE (UNII: FGL3685T2X) HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) PANTHENOL (UNII: WV9CM0O67Z) SAFFLOWER OIL (UNII: 65UEH262IS) CETEARYL OLIVATE (UNII: 58B69Q84JO) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) WITCH HAZEL (UNII: 101I4J0U34) CETYL ALCOHOL (UNII: 936JST6JCN) JOJOBA OIL (UNII: 724GKU717M) ARGAN OIL (UNII: 4V59G5UW9X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10842-203-02 946 mL in 1 JUG; Type 0: Not a Combination Product 06/20/2019 2 NDC:10842-203-01 89 mL in 1 TUBE; Type 0: Not a Combination Product 06/20/2019 3 NDC:10842-203-03 1893 mL in 1 JUG; Type 0: Not a Combination Product 06/20/2019 4 NDC:10842-203-04 6 mL in 1 PACKET; Type 0: Not a Combination Product 06/20/2019 5 NDC:10842-203-06 177 mL in 1 TUBE; Type 0: Not a Combination Product 06/20/2019 6 NDC:10842-203-08 89 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 06/20/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/20/2019 Labeler - DOCTOR HOY'S, LLC (791882322) Establishment Name Address ID/FEI Business Operations Specialty Formulations and Manufacturing LLC 003989912 manufacture(10842-203) , label(10842-203) Establishment Name Address ID/FEI Business Operations Dynamic Blending Specialists, Inc. 085704438 manufacture(10842-203) Establishment Name Address ID/FEI Business Operations United Laboratories Manufacturing, LLC 807878116 manufacture(10842-203) , label(10842-203)