Label: GRASTON REVIVE POST TREATMENT- hpus arnica montana cream
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Contains inactivated NDC Code(s)
NDC Code(s): 73080-100-01, 73080-100-02 - Packager: Graston Technique, LLC
- This is a repackaged label.
- Source NDC Code(s): 10842-203
- 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 5, 2022
If you are a consumer or patient 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
Inactive Ingredients: arnica montana extract, deionized water, hamamelis virginiana (witch hazel extract), isopropyl alcohol, cetyl alcohol, glycerin, tocopheryl acetate (vitamin E), aloe vera, argan oil, calendula oil, chamomile, hyperium Perforatum Extract, safflower oil, tilia cordata flower extract
- 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
GRASTON REVIVE POST TREATMENT
hpus arnica montana creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73080-100(NDC:10842-203) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - 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:73080-100-02 6 mL in 1 PACKET; Type 0: Not a Combination Product 05/01/2019 2 NDC:73080-100-01 119 mL in 1 TUBE; Type 0: Not a Combination Product 05/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/01/2019 Labeler - Graston Technique, LLC (079097263) Establishment Name Address ID/FEI Business Operations Specialty Formulations and Manufacturing LLC 003989912 manufacture(73080-100) , label(73080-100) Establishment Name Address ID/FEI Business Operations Dynamic Blending Specialists, Inc. 085704438 manufacture(73080-100) Establishment Name Address ID/FEI Business Operations United Laboratories Manufacturing, LLC 807878116 manufacture(73080-100) , relabel(73080-100)