Uncle Buds Pain Relief by CBH International LLC / TAKA USA Inc. dba Cosmetic Innovations CBH Pain Relief Gel

Uncle Buds Pain Relief by

Drug Labeling and Warnings

Uncle Buds 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]

UNCLE BUDS PAIN RELIEF- trolamine salicylate gel gel 
CBH International 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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CBH Pain Relief Gel

Active Ingredient

Trolamine Salicylate 10%

Purpose

Topical Analgesic

Use

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 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 Poison Control Center right away

Directions

Adults and children 2 years of age and older: Apply to affected area not mroe than 3 to 4 times daily. Children under 2 years of age: Consult a doctor.

Other Information

Store at ropom temperature. Avoic excessive heat.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Vera Leaf, Cannabis Sativa Seed Oil, Carbomer Homopolymer Unspecified Type, Diethylene Glycol Monoethyl Ether, Edetate Disodium, Ethylhexylglycerin, Ethylhexyl Palmitate, Fragrance, Phenoxyethanol, Water

Questions?

www.unclebudshemp.com

Tube Label

UNCLE BUDS PAIN RELIEF 
trolamine salicylate gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72680-014
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 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72680-014-01	100 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/01/2021	09/30/2022

Labeler - CBH International LLC (116834275)

Establishment
Name	Address	ID/FEI	Business Operations
TAKA USA Inc. dba Cosmetic Innovations		802860515	manufacture(72680-014)

Revised: 12/2022

Document Id: efa90d50-5a07-33dd-e053-2a95a90a6b71

34390-5

Set id: be4d2732-574c-d482-e053-2995a90ad3d0

Version: 2

Effective Time: 20221212