Uncle Buds Roll-On Pain Relief: Package Insert and Label Information

UNCLE BUDS ROLL-ON PAIN RELIEF- trolamine salicylate 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.

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

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TROLAMINE SALICYLATE (SALICYLIC ACID) TROLAMINE SALICYLATE 100 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
CARBOXYMETHYLCELLULOSE SODIUM
EDETATE DISODIUM (EDETIC ACID)
ETHYLHEXYLGLYCERIN
POLYGLYCERYL-10 OLEATE
WATER
ALLANTOIN
CANNABIS SATIVA SEED OIL
PHENOXYETHANOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72680-004-01 1 BOTTLE, WITH APPLICATOR in 1 CARTON contains a BOTTLE, WITH APPLICATOR
1 71 g in 1 BOTTLE, WITH APPLICATOR This package is contained within the CARTON (72680-004-01)
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 Operations
TAKA USA Inc. dba Cosmetic Innovations 802860515 manufacture (72680-004), analysis (72680-004)

Revised: 07/2019 CBH International LLC

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