EMU THERAPY RED HOT PEPPER PAIN RELIEF CREAM- menthol, capsaicin 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 Red Hot Pepper Pain Relief Cream

Active Ingredient:

Menthol, USP (2.75%)

Capsaicin (0.025%)

Purpose:

Topical Analgesic

Uses:

Temporary relief of minor aches and pains of muscles and joints. 

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:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, 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, Centaurea Cyanus (Corniflower) Extract, Chamomilla Recutita (Chamomile) Extract, Coriandrum Sativum (Coriander) Oil, Emu Oil, Ethylhexylglycerin, Hamamelis Virginiana (Witch Hazel), Helianthus Annuus (Sunflower) Oil, Hypericum Perforatum (St. John's Wort), Lamium Album (White Nettle) Extract, Methylsulfonyl Methane (MSM), Parfum (Fragrance), Phenoxyethanol, Salix Alba (Willow) Bark Extract, SD-Alcohol 40B, Sodium Lauryl Sulfate, Sorbitol, Tillia Cordata (Linden) Bark Extract, Triethanolamine, Fever Few Extract, FD&C Blue #1, FD&C Yellow #5.

Questions or Comments?

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

Package Labeling:

Label2

EMU THERAPY RED HOT PEPPER PAIN RELIEF CREAM 
menthol, capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83591-417
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL15 mg  in 1 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CHAMOMILE (UNII: FGL3685T2X)  
CORIANDER (UNII: 1OV56052IK)  
EMU OIL (UNII: 344821WD61)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
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)  
TROLAMINE (UNII: 9O3K93S3TK)  
TANACETUM PARTHENIUM WHOLE (UNII: 6GE7Z0761K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83591-417-00237 mL in 1 JAR; Type 0: Not a Combination Product08/08/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/08/2023
Labeler - ACA MANAGEMENT LLC (119034214)

Revised: 7/2023
Document Id: 0163bb79-9833-eb18-e063-6394a90a6737
Set id: 36293885-b2dd-4fba-9748-35a3c9e05078
Version: 3
Effective Time: 20230726
 
ACA MANAGEMENT LLC