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

UNCLE BUDS 
topical pain reliever gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70743-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70743-0001-1	30 g in 1 TUBE; Type 0: Not a Combination Product	07/22/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/22/2016

Labeler - Budsworth Labs LLC (080240053)

Registrant - Richard Hamer Associates LLC (067731889)

Establishment
Name	Address	ID/FEI	Business Operations
TAKA USA Inc dba Cosmetic Innovations		802860515	pack(70743-0001) , manufacture(70743-0001)

Revised: 7/2018

Document Id: 724d0889-5b95-3125-e053-2a91aa0a92c1

34390-5

Set id: 383e9536-b0bc-0496-e054-00144ff8d46c

Version: 3

Effective Time: 20180731