KRT ATHLETIC MUSCLE GEL- trolamine salicylate gel

KRT Athletic Muscle Gel by

Drug Labeling and Warnings

KRT Athletic Muscle Gel by is a Otc medication manufactured, distributed, or labeled by Cosmetic Specialty Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Incredient

Triethanolamine Salicylate 10%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with ​ arthritis simple backache muscle strains sprains bruises cramps

Warnings

for external use only

Allergy alert:

If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

WHEN USING

When using this product use only as directed avoid contact with eyes or mucous membranes do not apply to wounds or damaged skin

STOP USE

Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days redness is present irritation develops

KEEP OUT OF REACH OF CHILDREN

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Adults and children over 12 years: apply to affected area massage into painful area until thoroughly absorbed into skin repeat as necessary, but no more than 4 times daily

Children 12 years or younger: ask a doctor

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Arnica montana Flower Extract, Butylene Glycol, Caprylyl Clycol, Carbomer, Chamomila recutita (Matricaria) Flower Extract, Citric Acid, Citrus sinensis (Sweet Orange) Peel Oil, Creatine Monohydrate, Fragrance, Lactic Acid, Lauric Acid, Phenoxyethanol, Purified Water, Salvia officinalis (Sage) Extract, Sodium Caprylate, Sorbitol, Triethanolamine.

Package Label

INGREDIENTS AND APPEARANCE

KRT ATHLETIC MUSCLE GEL 
trolamine salicylate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58133-751
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ)	TROLAMINE SALICYLATE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
TROLAMINE (UNII: 9O3K93S3TK)
ORANGE OIL, DISTILLED (UNII: H4QNH2ZN7A)
SAGE (UNII: 065C5D077J)
SODIUM CAPRYLATE (UNII: 9XTM81VK2B)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CREATINE MONOHYDRATE (UNII: 9603LN7R2Q)
LACTIC ACID (UNII: 33X04XA5AT)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHAMOMILE (UNII: FGL3685T2X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LAURIC ACID (UNII: 1160N9NU9U)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white (opaque)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58133-751-03	89 mL in 1 TUBE; Type 0: Not a Combination Product	03/10/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/10/2021

Labeler - Cosmetic Specialty Labs, Inc. (032973000)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Specialty Labs, Inc.		032973000	manufacture(58133-751) , label(58133-751) , analysis(58133-751) , pack(58133-751)