UNCLE BUDS ROLL-ON PAIN RELIEF- trolamine salicylate gel gel

Uncle Buds Roll-On Pain Relief by

Drug Labeling and Warnings

Uncle Buds Roll-On Pain Relief by is a Otc medication manufactured, distributed, or labeled by CBH International LLC, TAKA USA Inc. dba Cosmetic Innovations. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Trolamine Salicylate 10%

Purpose

Topical analgesic

Uses

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

Warnings

For external use only

When using this product

• Avoid contact with eyes
• Do not apply to wounds or damaged skin
• Do not bandage tightly

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

Keep out of reach of children

If swallowed, get medical help or contact a Posion Control Center right away.

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: Consult a doctor.

Other Information

Store at room temperature. Avoid excessive heat.

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Cannabis Sativa Seed Oil, Cellulose Gum, Disodium EDTA, Ethylhexylglycerin, Fragrance, Phenoxyethanol, Polyglyceryl-10 Oleate, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UNCLE BUDS ROLL-ON PAIN RELIEF 
trolamine salicylate gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72680-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ)	TROLAMINE SALICYLATE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH)
WATER (UNII: 059QF0KO0R)
ALLANTOIN (UNII: 344S277G0Z)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72680-004-01	1 in 1 CARTON	02/05/2019
1		71 g in 1 BOTTLE, WITH APPLICATOR; 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	02/05/2019

Labeler - CBH International LLC (116834275)

Establishment
Name	Address	ID/FEI	Business Operations
TAKA USA Inc. dba Cosmetic Innovations		802860515	manufacture(72680-004) , analysis(72680-004)