AGERANIUM PATCH- capsaicin patch 
Entom 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.

----------

Ageranium Patch

Active ingredient

Capsacin 0.228mg

Purpose

External analgesic

Uses

For temporary relief of minor aches & pains of muscles & joints associated with:

- arthritis

- simple backace

- strains

- bruises

- sprains

Warnings

For external use only

Allergy alert: If prone to have an allergic reaction to Capsaicin, cunsult a doctor before use.

Do not use

- on wounds or damaged skin

- if you are allergic to any ingredients of this product

When using this product

- use only as directed

- avoid contact with the eyes, mucous membran, and rashes

- wrap the bandage not too tight

Stop use and ask a doctor if

- Rash, itching, or excessive skin irritation develops

- conditions worsen

- symptoms persist for more than 7 days

- symptoms clear up and occur again within a few days

If pregnant or breas-feeding

- ask a health professional before use.

Keep out of reach of children

Keep out or reach of children

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

Directions

Adults and children over 12 years of age

- clean and dry affected area

- remove patch from film

- remove patch slowly and gentle from the skin after at most 8 hours application

Children under 12 years of age:

consult a doctor

Inactive ingredients

Zinc oxide, Polybutene

Ageranium Patch

geranium patch

AGERANIUM PATCH 
capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71955-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.228 mg  in 99.13 mg
Inactive Ingredients
Ingredient NameStrength
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71955-100-028 in 1 BOX12/29/2017
1NDC:71955-100-014 in 1 POUCH
1NDC:71955-100-0099.13 mg in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/29/2017
Labeler - Entom Co., Ltd. (690106385)
Registrant - Lanec Inc. (052790515)
Establishment
NameAddressID/FEIBusiness Operations
Entom Co., Ltd.690106385manufacture(71955-100)

Revised: 12/2017
Document Id: 6182bea6-1607-c6f9-e053-2a91aa0a5f51
Set id: 6182bea6-1606-c6f9-e053-2a91aa0a5f51
Version: 1
Effective Time: 20171229
 
Entom Co., Ltd.