arex sinsin medium

SPL v10

SPL

SPL Set ID 2013ea44-e2ea-4b36-bddb-7f64163284b6

Routes

cutaneous transdermal topical

Published

Effective Date 2015-08-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

levomenthol (45.45 mg) salicylic acid (215.91 mg) zinc oxide (17.05 mg) camphor (synthetic) (22.73 mg) peppermint

Inactive Ingredients

benzyl nicotinamide butylated hydroxytoluene calcium carbonate glycerin rosin natural latex rubber polyisobutylene (200000 mw) polybutene (1400 mw) nonivamide

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2015-08-31

Purpose

Topical Analgesic

Description

DL-Camphor 17.05mg L-Menthol 45.45mg Mentha Oil 22.73mg Methyl Salicylate 45.45mg Zinc Oxide 215.91mg

Medication Information

Uses

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

arthritis
simple backache
strains
bruises
sprains

Purpose

Topical Analgesic

Directions

Adults and children 12 years of age and over:

Clean and dry affected area
Remove patch from film.
Apply to affected area not 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.

Other Information

avoid storing product in direct sunlight
protect from excessive moisture

Inactive Ingredients

Benzyl Nicothinamide, Butylated Hydroxytoluene, Calcium Carbonate, Glyceryl Rosinate, Natural Rubber, Polyisobutylene, Polybutene, Quintone, Vanillyl Nonylamide, YS Resin.

FDA NDC No.: 55264-020-10

Description

DL-Camphor 17.05mg L-Menthol 45.45mg Mentha Oil 22.73mg Methyl Salicylate 45.45mg Zinc Oxide 215.91mg

Principal Display Panel

Caution:

This product contains natural rubber latex which may cause allergic reactions.

Do Not Use

on wounds or damaged skin
if you are allergic to aspirin or salicylates
with a heating pad
with, or at the same time as, other external analgesic products.

Manufactured By:

SINSIN PHARM. CO., LTD.

90, Beomjigi-ro 141 beon-gil, Danwon-gu, Ansan-si, Gyeonggi-do, Korea

tel: 82-31-776-1140~3 http://www.sinsin.com

Active Ingredients

DL-Camphor 17.05mg

L-Menthol 45.45mg

Mentha Oil 22.73mg

Methyl Salicylate 45.45mg

Zinc Oxide 215.91mg

Ask A Doctor Before Use

if you are allergic to any ingredients of this product

When Using This Product

do not use otherwise than directed.
avoid contact with the eyes, mucous membranes or rashes.

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.

Keep Out of Reach of Children.

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

Structured Label Content

Uses

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

arthritis
simple backache
strains
bruises
sprains

Purpose

Topical Analgesic

Directions

Adults and children 12 years of age and over:

Clean and dry affected area
Remove patch from film.
Apply to affected area not 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.

Other Information (Other information)

avoid storing product in direct sunlight
protect from excessive moisture

Inactive Ingredients (Inactive ingredients)

Benzyl Nicothinamide, Butylated Hydroxytoluene, Calcium Carbonate, Glyceryl Rosinate, Natural Rubber, Polyisobutylene, Polybutene, Quintone, Vanillyl Nonylamide, YS Resin.

FDA NDC No.: 55264-020-10

Principal Display Panel

Caution:

This product contains natural rubber latex which may cause allergic reactions.

Do Not Use (Do not use)

on wounds or damaged skin
if you are allergic to aspirin or salicylates
with a heating pad
with, or at the same time as, other external analgesic products.

Manufactured By: (Manufactured by:)

SINSIN PHARM. CO., LTD.

90, Beomjigi-ro 141 beon-gil, Danwon-gu, Ansan-si, Gyeonggi-do, Korea

tel: 82-31-776-1140~3 http://www.sinsin.com

Active Ingredients (Active ingredients)

DL-Camphor 17.05mg

L-Menthol 45.45mg

Mentha Oil 22.73mg

Methyl Salicylate 45.45mg

Zinc Oxide 215.91mg

Ask A Doctor Before Use (Ask a doctor before use)

if you are allergic to any ingredients of this product

When Using This Product (When using this product)

do not use otherwise than directed.
avoid contact with the eyes, mucous membranes or rashes.

Stop Use and Ask A Doctor If (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.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Advanced Ingredient Data

[{"name": "BENZYL NICOTINAMIDE", "unii": "HF1W0213QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLATED HYDROXYTOLUENE", "unii": "1P9D0Z171K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM CARBONATE", "unii": "H0G9379FGK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ROSIN", "unii": "88S87KL877", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NATURAL LATEX RUBBER", "unii": "2LQ0UUW8IN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYISOBUTYLENE (200000 MW)", "unii": "Z6Y02I0591", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYBUTENE (1400 MW)", "unii": "1NA5AO9GH7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NONIVAMIDE", "unii": "S846B891OR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LEVOMENTHOL", "unii": "BZ1R15MTK7", "classCode": "ACTIB", "strengthNumerator": "45.45", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "45.45", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "215.91", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "ACTIB", "strengthNumerator": "17.05", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PEPPERMINT", "unii": "V95R5KMY2B", "classCode": "ACTIB", "strengthNumerator": "22.73", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "For temporary relief of minor aches and pains of muscles and joints associated with: arthritis simple backache strains bruises sprains", "Purpose": "Topical Analgesic", "Caution:": "This product contains natural rubber latex which may cause allergic reactions.", "Directions": "Adults and children 12 years of age and over: Clean and dry affected area Remove patch from film. Apply to affected area not 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.", "Do not use": "on wounds or damaged skin if you are allergic to aspirin or salicylates with a heating pad with, or at the same time as, other external analgesic products.", "Manufactured by:": "SINSIN PHARM. CO., LTD. 90, Beomjigi-ro 141 beon-gil, Danwon-gu, Ansan-si, Gyeonggi-do, Korea tel: 82-31-776-1140~3 http://www.sinsin.com", "Other information": "avoid storing product in direct sunlight protect from excessive moisture", "Active ingredients": "DL-Camphor 17.05mg L-Menthol 45.45mg Mentha Oil 22.73mg Methyl Salicylate 45.45mg Zinc Oxide 215.91mg", "Inactive ingredients": "Benzyl Nicothinamide, Butylated Hydroxytoluene, Calcium Carbonate, Glyceryl Rosinate, Natural Rubber, Polyisobutylene, Polybutene, Quintone, Vanillyl Nonylamide, YS Resin. FDA NDC No.: 55264-020-10", "Ask a doctor before use": "if you are allergic to any ingredients of this product", "When using this product": "do not use otherwise than directed. avoid contact with the eyes, mucous membranes or rashes.", "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.", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:14.476230 · Updated: 2026-03-14T23:12:56.390264