OTC Medication Information: KT Recovery Plus Pain Relief Gel

KT RECOVERY PLUS PAIN RELIEF GEL- menthol and camphor (natural) 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.

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

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KT RECOVERY PLUS PAIN RELIEF GEL camphor, menthol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73044-102(NDC:10842-102)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 50 mg in 1 mL
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL) 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ARNICA MONTANA
WATER
WITCH HAZEL
ISOPROPYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73044-102-03 5 mL in 1 PACKET None
2 NDC:73044-102-01 100 mL in 1 TUBE None
3 NDC:73044-102-02 89 mL in 1 BOTTLE, WITH APPLICATOR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 05/01/2019
Labeler — KT Health LLC (807008037)
Establishment
Name Address ID/FEI Operations
Specialty Formulations and Manufacturing LLC 003989912 relabel (73044-102)

Revised: 11/2020 KT Health LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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