EMU THERAPY COOL MENTHOL THERAPY PAIN RELIEF CREAM- menthol cream
ACA MANAGEMENT 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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EMU THERAPY Cool Menthol Therapy Pain Relief Cream

Active Ingredient:

Menthol, USP (2.75%)

Purpose:

Topical Analgesic

Uses:

Temporary relief of minor aches and pains associated with arthritis, simple backache, strains, sprains, and bruises.

Warnings:

For external use only.

Do not use

on wounded, damaged or irritated skin.

When using this product

avoid contact with eyes or mucous membranes, do not bandage tightly.

Stop use and ask a doctor

if you experience a rash and/or a reaction, condition worsens, or if symptoms persist for more than 10 days or clear up and occur again within a few days.

If pregnant or Breast-Feeding

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

For adults and children 2 years of age and older: apply to affected area not more than 3 or 4 times a day. Consult a doctor before using for children under 2 years of age.

Inactive Ingredients:

Aloe Barbadensis leaf (Aloe Vera Gel) Juice, Anthemis Nobilis (Roman Chamomile) Oil, Aqua (Deionized water), Arnica Montana Flower Extract, Ascorbyl Palmitate (Vitamin C), Calendula Officinalis Extract, Capsaicin, Carbomer, Centaurea Cyanus (Cornflower) Extract, Chamomilla Matricaria (Chamomile) Extract, Coriandrum Sativum (Coriander) Oil, Emu Oil, Ethylhexylglycerin, FD&C Blue #1; FD&C Yellow #5, Glycerin, Hamamelis Virginiana (Witch Hazel), Helianthus Annuus (Sunflower) Oil, Hypericum Perforatum (St. John's Wort), Lamium Album (White Nettle) Extract, Methylsulfonylmethane (MSM), Parfum (Fragrance), Phenoxyethanol, Salix Alba (Willow) Bark Extract, SD-Alohol 40B, Sodium Lauryl Sulfate, Sorbitol, Tanacetum Parthenium (Feverfew) Extract, Tilla Cordata (Linden) Bark Extract, Triethanolamine.

Questions or Comments?

1-800-222-0554 or www.coolmentholTheropyPainCream.com

Package Labeling:

Label

EMU THERAPY COOL MENTHOL THERAPY PAIN RELIEF CREAM
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83591-416
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	27.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CAPSAICIN (UNII: S07O44R1ZM)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CHAMOMILE (UNII: FGL3685T2X)
CORIANDER (UNII: 1OV56052IK)
EMU OIL (UNII: 344821WD61)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GLYCERIN (UNII: PDC6A3C0OX)
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)
HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB)
LAMIUM ALBUM WHOLE (UNII: 046Y1357I6)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SALIX ALBA BARK (UNII: 205MXS71H7)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SORBITOL (UNII: 506T60A25R)
FEVERFEW (UNII: Z64FK7P217)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83591-416-00	237 mL in 1 JAR; Type 0: Not a Combination Product	08/08/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/08/2023

Labeler - ACA MANAGEMENT LLC (119034214)

Revised: 7/2023

Document Id: 0163cef0-bd7e-93da-e063-6394a90a8712

Set id: 16894346-3513-41b1-b09f-72d84edcc4ac

Version: 3

Effective Time: 20230726

ACA MANAGEMENT LLC