Label: DOCTOR HOYS NATURAL PAIN RELIEF- camphor, menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 10842-102-01, 10842-102-02, 10842-102-03, 10842-102-04, view more10842-102-05, 10842-102-08, 10842-102-09 - Packager: DOCTOR HOY'S, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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)
- ACTIVE INGREDIENT
- PURPOSE
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KEEP OUT OF REACH OF CHILDREN
Warnings:
* for external use only * do not apply to wounds or damaged skin or bandage tightly * 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 -
INACTIVE INGREDIENT
Inactive Ingredients:
distilled water, hamamelis virginiana (witch hazel extract),
isopropyl alcohol, arnica Montana, oleyl alcohol and
zanthoxylum alatum (scezhuan pepper), Bio-saccharide
Gum -1, glycerin, ammonium acryloyldimethyltaurate/VP
copolymer, beta cyclodextrin, menthol, potassium hydroxide,
mannitol, cellulose chromium, hydroxide green, tocopheryl
acetate (vitamin E), hydroxypropyl methycellulose -
DOSAGE & ADMINISTRATION
Directions:
for adults and children 2 years and older; apply to affected area not more than 3 to 4 times daily. "Children under 2 years of age: consult a doctor." Apply generously to affected and surrounding areas. Rub in well. Use 1 application for minor pain, 2 for medium and 3 applications for severs symptoms. Allow to dry between applications (usually just 2-3 minutes). -
INDICATIONS & USAGE
Directions:
for adults and children 2 years and older; apply to affected area not more than 3 to 4 times daily. "Children under 2 years of age: consult a doctor." Apply generously to affected and surrounding areas. Rub in well. Use 1 application for minor pain, 2 for medium and 3 applications for severs symptoms. Allow to dry between applications (usually just 2-3 minutes).Uses:
for the temporary relief of minor aches and pains of muscles
and joints due to:
* simple backache
* arthritis
* sprains
* strains
* bruises
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WARNINGS
Warnings:
* for external use only
* do not apply to wounds or damaged skin or bandage tightly
* 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 - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DOCTOR HOYS NATURAL PAIN RELIEF
camphor, menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10842-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 50 mg in 1 mL CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength EUPHORBIA ANTISYPHILITICA WHOLE (UNII: 82A88H0RIQ) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) GLYCERIN (UNII: PDC6A3C0OX) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) ARNICA MONTANA (UNII: O80TY208ZW) WATER (UNII: 059QF0KO0R) WITCH HAZEL (UNII: 101I4J0U34) ISOPROPYL ALCOHOL (UNII: ND2M416302) POLYGLYCERYL-10 CAPRYLATE (UNII: YS396CQX5C) ZANTHOXYLUM BUNGEANUM FRUIT (UNII: 3CIP16A418) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) HYDRATED SILICA (UNII: Y6O7T4G8P9) OLEYL ALCOHOL (UNII: 172F2WN8DV) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) MANNITOL (UNII: 3OWL53L36A) PHENOXYETHANOL (UNII: HIE492ZZ3T) MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10842-102-01 237 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 05/10/2005 2 NDC:10842-102-02 1814 mL in 1 JUG; Type 0: Not a Combination Product 05/10/2005 3 NDC:10842-102-04 5 mL in 1 PACKET; Type 0: Not a Combination Product 05/10/2005 4 NDC:10842-102-05 946 mL in 1 JUG; Type 0: Not a Combination Product 08/05/2015 5 NDC:10842-102-08 89 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 09/01/2015 6 NDC:10842-102-09 3785 mL in 1 JUG; Type 0: Not a Combination Product 05/10/2005 7 NDC:10842-102-03 118 mL in 1 TUBE; Type 0: Not a Combination Product 09/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/10/2005 Labeler - DOCTOR HOY'S, LLC (791882322) Registrant - DOCTOR HOY'S, LLC (791882322) Establishment Name Address ID/FEI Business Operations Specialty Formulations and Manufacturing LLC 003989912 manufacture(10842-102) , label(10842-102) Establishment Name Address ID/FEI Business Operations Dynamic Blending Specialists, Inc. 085704438 manufacture(10842-102) Establishment Name Address ID/FEI Business Operations United Laboratories Manufacturing, LLC 807878116 manufacture(10842-102) , label(10842-102)
