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.

----------

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70743-0001-1	30 g in 1 TUBE; Type 0: Not a Combination Product	07/22/2016

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

Labeler - Budsworth Labs LLC (080240053)

Registrant - Richard Hamer Associates LLC (067731889)

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

Revised: 7/2018

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

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

Version: 3

Effective Time: 20180731

Budsworth Labs LLC