Uncle Buds by Budsworth Labs LLC / Richard Hamer Associates LLC / TAKA USA Inc dba Cosmetic Innovations

Uncle Buds by

Drug Labeling and Warnings

Uncle Buds by is a Otc medication manufactured, distributed, or labeled by Budsworth Labs LLC, Richard Hamer Associates LLC, TAKA USA Inc dba Cosmetic Innovations. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

UNCLE BUDS- topical pain reliever gel 
Budsworth Labs 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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Active Ingredient

Methyl Salicylate 10%

Purpose

Counterirritant

Uses

For the 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 the 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 Poison 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. Rub in throroughly before contact with clothing. Children under 2 years of age: Consult a doctor.

Other Information

  • Store at room temperature
  • Avoid excessive heat

Inactive Ingredients

Cannabis Sativa Seed Oil, Cetearyl Olivate, Coconut Oil, Emu Oil, PEG-12 Glyceryl Dimyristate, Sorbitan Olivate

PDP

UNCLE BUDS 
topical pain reliever gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70743-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITAN OLIVATE (UNII: MDL271E3GR)  
COCONUT OIL (UNII: Q9L0O73W7L)  
PEG-12 GLYCERYL DIMYRISTATE (UNII: VS4W16AQ3X)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
EMU OIL (UNII: 344821WD61)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70743-0001-130 g in 1 TUBE; Type 0: Not a Combination Product07/22/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/22/2016
Labeler - Budsworth Labs LLC (080240053)
Registrant - Richard Hamer Associates LLC (067731889)
Establishment
NameAddressID/FEIBusiness Operations
TAKA USA Inc dba Cosmetic Innovations802860515pack(70743-0001) , manufacture(70743-0001)

Revised: 7/2018
 

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