CHO-A PAP- menthol, zinc oxide patch

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Menthol (4.6%), Zinc Oxide (10.6%)
Available from:
Cho-A Pharm.Co.,Ltd.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Topical Analgesic Topical Analgesic Arthritis Simple backache Strains Bruises Sprains
Authorization status:
OTC monograph not final
Authorization number:
58354-115-01, 58354-115-02

CHO-A PAP- menthol, zinc oxide patch

Cho-A Pharm.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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Cho-a PAP

Active Ingredients

Menthol (4.6%)

Zinc Oxide (10.6%)

Purpos e

Topical Analgesic

Topical Analgesic

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical

attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Us es

Arthritis

Simple backache

Strains

Bruises

Sprains

Warnings

For external use only

Do not use

on wounds or damaged skin

if you are allergic to any ingredients of this product

with a heating pad

with, or at the same time as, other external

analgesic products

When using this product

do not use otherwise than directed

avoid contact with eyes, mucous membranes or rashes

do not bandage tightly

Ask a doctor before use if you are prone to allergic reaction from aspirin or salicylate

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

Directions

Adults and children 12 years of age and over:

Clean and dry affected area

Remove patch from film

Apply 1 patch at a time to affected area, no more than 3 to 4 times daily for 7 days

Remove patch from skin after at most 8 hours application

Children under 12 years of age: consult a doctor

Inactive Ingredients

Liquid paraffin, Peppermint Oil, Purified Lanolin, Silica, Titanium dioxide.

CHO-A PAP

CHO-A PAP

menthol, zinc oxide patch

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:58 354-115

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

ZINC OXIDE

40 7 mg in 3.8 5 g

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

177 mg in 3.8 5 g

Inactive Ingredients

Ingredient Name

Stre ng th

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

9 2 mg in 3.8 5 g

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:58 354-115-0 2

6 in 1 POUCH

0 3/15/20 19

1

NDC:58 354-115-0 1

3.8 5 g in 1 PATCH; Type 0 : No t a Co mbinatio n Pro duct

Cho-A Pharm.Co.,Ltd.

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 3/15/20 19

Labeler -

Cho-A Pharm.Co.,Ltd. (688056831)

Registrant -

Cho-A Pharm.Co.,Ltd. (688056831)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Cho -A Pharm.Co .,Ltd.

6 8 8 0 56 8 31

ma nufa c ture (58 354-115)

Revised: 3/2019

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