ACHY- menthol cream cream 
Kelada Creative Group LLC DBA SALVE

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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Achy external analgesic

Menthol 1.5%

Temporarily relieves the minor aches and pains associated with tendonitis, backache, leg cramps, sore muscles, arthritis, bruises, sprains, and swelling.

Warnings

For external use only.

Do not use other than directed

When using this product

Stop use and ask a doctor if

Adults and children 3 years of age and older liberally massage to affected are not more than 4 times daily

Children under 3 years of age ask a doctor before using

Organic extra virgin olive oil, organic comfrey oil, organic arnica oil, beeswax, Indian lemongrass essenttial oil, French clary sage essential oil, Spanish rosemary essential oil, and Natural Vitamin E

Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away (1-800-222-1222

Temporarily relieves the minor aches and pains associated with tendonitis, backache, leg cramps, sore muscles, arthritis, bruises, sprains, and swelling.​

Achy

ACHY 
menthol cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71157-0017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL28 g  in 90 mL
Inactive Ingredients
Ingredient NameStrength
OLIVE OIL (UNII: 6UYK2W1W1E)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
COMFREY LEAF (UNII: DG4F8T839X)  
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
WHITE WAX (UNII: 7G1J5DA97F)  
CLARY SAGE OIL (UNII: 87L0D4U3M0)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71157-0017-190 mL in 1 CAN; Type 0: Not a Combination Product12/19/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/19/2016
Labeler - Kelada Creative Group LLC DBA SALVE (014340121)
Registrant - Kelada Creative Group LLC DBA SALVE (014340121)
Establishment
NameAddressID/FEIBusiness Operations
Kelada Creative Group LLC DBA SALVE014340121manufacture(71157-0017)

Revised: 12/2016
Document Id: 43b92d37-1562-003b-e054-00144ff88e88
Set id: 43b92d37-1561-003b-e054-00144ff88e88
Version: 1
Effective Time: 20161215
 
Kelada Creative Group LLC DBA SALVE