KT Health

KT Health

Drug Labeling and Warnings

Drug Details

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KT RECOVERY PLUS PAIN RELIEF GEL- camphor, menthol gel 
KT Health 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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KT Health

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),

ethanol 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, 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

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

KT RECOVERY PLUS PAIN RELIEF GEL 
camphor, menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73044-102(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
ARNICA MONTANA (UNII: O80TY208ZW)  
WATER (UNII: 059QF0KO0R)  
WITCH HAZEL (UNII: 101I4J0U34)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73044-102-035 mL in 1 PACKET; Type 0: Not a Combination Product05/01/2019
2NDC: 73044-102-01100 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2019
3NDC: 73044-102-0289 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/01/2019
Labeler - KT Health LLC (807008037)

Revised: 1/2020
 
KT Health LLC


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