DOCTOR HOYS NATURAL PAIN RELIEF - menthol and camphor (natural) 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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DRUG FACTS

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: MM1bottle label

DOCTOR HOYS NATURAL PAIN RELIEF  
menthol, camphor gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:10842-100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL50 mg  in 1 mL
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL)50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
arnica montana 
water 
Witch hazel 
ISOPROPYL ALCOHOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10842-100-01226 mL in 1 BOTTLE, DISPENSING
2NDC:10842-100-021814 mL in 1 JUG
3NDC:10842-100-03120 mL in 1 TUBE
4NDC:10842-100-045 mL in 1 PACKET
5NDC:10842-100-05946 mL in 1 JUG
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
Northwest Cosmetic Labs929572014manufacture(10842-100)

Revised: 7/2013
 
DOCTOR HOY'S, LLC