ACHY- menthol cream cream

Achy by

Drug Labeling and Warnings

Achy by is a Otc medication manufactured, distributed, or labeled by Kelada Creative Group LLC DBA SALVE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 1.5%

PURPOSE

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

WARNINGS

Warnings

For external use only.

Do not use other than directed

When using this product

• avoid contact with eyes and mucous membranes
• do not apply tp wounds or broken skin

Stop use and ask a doctor if

• excessive skin irritation develops
• condition worsens

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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

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

INDICATIONS & USAGE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACHY 
menthol cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71157-0017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	28 g  in 90 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71157-0017-1	90 mL in 1 CAN; Type 0: Not a Combination Product	12/19/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/19/2016

Labeler - Kelada Creative Group LLC DBA SALVE (014340121)

Registrant - Kelada Creative Group LLC DBA SALVE (014340121)

Establishment
Name	Address	ID/FEI	Business Operations
Kelada Creative Group LLC DBA SALVE		014340121	manufacture(71157-0017)