DOCTOR HOYS NATURAL PAIN RELIEF- camphor, menthol gel 
DOCTOR HOY'S, LLC

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.

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Pain Relief Gel

Active Ingredients      Purpose

Camphor (5%)          External Analgesic        
Menthol (5%)          External Analgesic








Uses:
for the temporary relief of minor aches and pains of muscles and joints due to:
* simple backache * arthritis * sprains * strains * bruises

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 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

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).

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

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

An image/jpeg of the container label is included in this section.

 ID: MM1 bottle label

DOCTOR HOYS NATURAL PAIN RELIEF 
camphor, menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10842-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 mL
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10842-102-01237 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product05/10/2005
2NDC:10842-102-021814 mL in 1 JUG; Type 0: Not a Combination Product05/10/2005
3NDC:10842-102-045 mL in 1 PACKET; Type 0: Not a Combination Product05/10/2005
4NDC:10842-102-05946 mL in 1 JUG; Type 0: Not a Combination Product08/05/2015
5NDC:10842-102-0889 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product09/01/2015
6NDC:10842-102-093785 mL in 1 JUG; Type 0: Not a Combination Product05/10/2005
7NDC:10842-102-03118 mL in 1 TUBE; Type 0: Not a Combination Product09/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/10/2005
Labeler - DOCTOR HOY'S, LLC (791882322)
Registrant - DOCTOR HOY'S, LLC (791882322)
Establishment
NameAddressID/FEIBusiness Operations
Specialty Formulations and Manufacturing LLC003989912manufacture(10842-102) , label(10842-102)
Establishment
NameAddressID/FEIBusiness Operations
Dynamic Blending Specialists, Inc.085704438manufacture(10842-102)
Establishment
NameAddressID/FEIBusiness Operations
United Laboratories Manufacturing, LLC807878116manufacture(10842-102) , label(10842-102)

Revised: 12/2022
Document Id: ef195bfa-447b-e58b-e053-2a95a90a7073
Set id: 898f7784-693f-46f6-a9ac-778e0e6aa3b6
Version: 19
Effective Time: 20221205
 
DOCTOR HOY'S, LLC