KT RECOVERY PLUS PAIN RELIEF GEL- camphor, menthol gel

KT Recovery Plus Pain Relief Gel by

Drug Labeling and Warnings

KT Recovery Plus Pain Relief Gel by is a Otc medication manufactured, distributed, or labeled by KT Health LLC, Adonis Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                                                     Purpose

Camphor (5%)                                                  Topical Analgesic

Menthol (5%)                                                     Topical Analgesic

PURPOSE

Uses

Temporary relief of minor aches and pains in muscles and joints associated with: simple backache strains sprains
arthritis bruises

Warnings

For external use only
Do not apply to wounds or damaged skin
Do not 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
If pregnant or breast feeding, ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

Directions

For best results, shake well and apply generously
Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
For children under 2 years of age: Consult a doctor

INACTIVE INGREDIENT

Water, Alcohol, Glycerin, Tocopheryl Acetate, ButyrospermumParkii (Shae Butter) Extract, Arnica Montana Flower Extract, Hamamelis Virginiana (Witch Hazel) Extract, Ammonium Acryloyldimethyltaurate/VP Copolymer, Euphorbia Cerifera (Candelilla) Wax, Sodium Starch Octenylsuccinate,
Bio-Saccharide Gum-1, Phenoxyethanol, Hydrated Silica, Ethylhexylglycerin

Product label

INGREDIENTS AND APPEARANCE

KT RECOVERY PLUS PAIN RELIEF GEL 
camphor, menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73044-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g  in 100 mL
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SHEANUT (UNII: 84H6HBP32L)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
CANDELILLA WAX (UNII: WL0328HX19)
OCTENYLSUCCINIC ACID (UNII: 12UZE4X73L)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73044-103-01	100 mL in 1 TUBE; Type 0: Not a Combination Product	04/15/2023
2	NDC: 73044-103-02	1 in 1 BOX	04/15/2023
2		89 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/15/2023

Labeler - KT Health LLC (807008037)

Establishment
Name	Address	ID/FEI	Business Operations
Adonis Inc		116983147	manufacture(73044-103)