Sinsinpas Arex Instant Pain Relief Small

Sinsinpas Arex Instant Pain Relief Small
SPL v2
SPL
SPL Set ID c5ef616b-76c9-347f-e053-2a95a90a1dfa
Routes
CUTANEOUS TOPICAL TRANSDERMAL
Published
Effective Date 2021-06-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (34.1 mg) Peppermint (45.46 mg) Levomenthol (90.9 mg) Salicylic Acid (431.82 mg) Zinc Oxide
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 2021-06-29

Description

DL-Camphor 34.10mg L-Menthol 90.90mg Mentha Oil 45.46mg Methyl Salicylate 90.90mg Zinc Oxide 431.82mg

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

DL-Camphor 34.10mg L-Menthol 90.90mg Mentha Oil 45.46mg Methyl Salicylate 90.90mg Zinc Oxide 431.82mg

Uses

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

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains

Warnings

For external use only

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

Ask a doctor before use if you are allergic to any ingredients in this product.

When using this product

  • Do not use other than directed
  • Avoid contact with eyes, mucous membranes, and rashes

Stop use and ask a doctor if

  • Rash, itching, or excessive skin irritation develops
  • Condition worsens
  • Symptoms persist for longer than 7 days
  • Symptoms clear up and reoccur 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.

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.
Distributed By:

SINSIN PHARM AMERICA

Brea, CA 92821

www.sinsinpas.us

Other Information
  • avoid storing product in direct sunlight
  • protect from excessive moisture

Active Ingredients

DL-Camphor 34.10mg

L-Menthol 90.90mg

Mentha Oil 45.46mg

Methyl Salicylate 90.90mg

Zinc Oxide 431.82mg

Inactive Ingredients

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

FDA NDC No.: 55264-021-06

Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of children


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

Warnings

For external use only

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

Ask a doctor before use if you are allergic to any ingredients in this product.

When using this product

  • Do not use other than directed
  • Avoid contact with eyes, mucous membranes, and rashes

Stop use and ask a doctor if

  • Rash, itching, or excessive skin irritation develops
  • Condition worsens
  • Symptoms persist for longer than 7 days
  • Symptoms clear up and reoccur 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.

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.
Distributed By: (Distributed by:)

SINSIN PHARM AMERICA

Brea, CA 92821

www.sinsinpas.us

Other Information (Other information)
  • avoid storing product in direct sunlight
  • protect from excessive moisture

Active Ingredients (Active ingredients)

DL-Camphor 34.10mg

L-Menthol 90.90mg

Mentha Oil 45.46mg

Methyl Salicylate 90.90mg

Zinc Oxide 431.82mg

Inactive Ingredients (Inactive ingredients)

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

FDA NDC No.: 55264-021-06

Principal Display Panel

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

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

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