EAGLE- menthol capsaicin patch 
Henan Lingrui Pharmaceutical Co Ltd

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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Drug Facts

Active Ingredients

Capsaicin 0.0625%

Menthol 3.4%

Purpose

External Analgesic

External Analgesic

Uses

for the temporarily relief of minor pains and aches of muscles and joints associated with ■ simple backache ■ arthritis ■ strains

■ bruises ■ sprains

Warnings

For external use only Avoid getting into the eyes or on mucous membranes. This product containsdry natural rubber which may cause allergic reactions

Caution: The Packaging of this product Contains Dry Natural Rubber

When using this product

■ do not appply to wounds or damaged skin ■ do not bandage tightly ■ do not use otherwise than as directed ■ do not use on children under 12 years of age with arthritis like conditions

Stop use and ask a doctor if

■ condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days ■ pain persists for more than 10 days ■ redness is present

Keep out of reach of children

to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately

Directions

■ remove patch from packet ■ cut patch to size ■ peel off protective backing and apply adhesive side to affected area

adults and children 2 years of age and older apply to affected area not more than 3 to 4 times daily

children under 2 years of age do not use, consult a doctor

Other Information

■ store in a cool place away from sunlight

■ keep unused plasters in the original packaging

Inactive Ingredients

beeswax, gum resin, lanolin, rubber and zinc oxide

Package Label

Package Label

EAGLE 
menthol capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42217-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0625 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.4 g
Inactive Ingredients
Ingredient NameStrength
BOSWELLIA SACRA WHOLE (UNII: 8O600AZL0W)  
LANOLIN (UNII: 7EV65EAW6H)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42217-300-066 in 1 PACKET; Type 0: Not a Combination Product08/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/01/2016
Labeler - Henan Lingrui Pharmaceutical Co Ltd (530021062)

Revised: 8/2016
Document Id: 3afcd2bf-94f7-11c9-e054-00144ff8d46c
Set id: 3afcd2bf-94f6-11c9-e054-00144ff8d46c
Version: 1
Effective Time: 20160826
 
Henan Lingrui Pharmaceutical Co Ltd