Pomada Dragon Pain Relieving Muscle Rub Cream 2oz 164

Pomada Dragon Pain Relieving Muscle Rub Cream 2oz 164
SPL v12
SPL
SPL Set ID c283291d-feaa-4f89-8fde-9e3957ea8b9f
Route
TOPICAL
Published
Effective Date 2015-03-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (40 mg) Menthol (100 mg) Salicylic Acid (300 mg)
Inactive Ingredients
Glyceryl Monostearate Ethylparaben Polysorbate 80 Water Sorbitan Monooleate Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-07-31

Description

Active ingredients                                                                             Purpose Camphor 4%.................................................................................Topical analgesic Menthol 10%.................................................................................Topical analgesic Methyl Salicylate 30%.....................................................................Topical analgesic


Medication Information

Warnings and Precautions

Warnings

For external use only

Allergy alert

  • if prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
Indications and Usage

Directions

  • use only as directed
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor
Dosage and Administration

Distributed By:

Genomma Lab USA, Inc.

Houston, TX 77027

Made in China

Description

Active ingredients                                                                             Purpose Camphor 4%.................................................................................Topical analgesic Menthol 10%.................................................................................Topical analgesic Methyl Salicylate 30%.....................................................................Topical analgesic

Section 44425-7

Other information

  • Store between 20 o and 25 o C (68 o and 77 oF)
Section 50565-1

Keep out of reach of children to avoid accidental ingestion.

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

Section 50566-9

Stop use and ask a doctor if

  • redness is present or irritation or rash develops
  • conditions worsen or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
Section 50567-7

When using this product

  • do not use otherwise than as directed
  • avoid contact with eyes or mucous membranes or rashes
  • do not bandage tightly
Section 50569-3

Ask a doctor before use

if you have redness over the affected area

Section 50570-1

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12years of age with arthritis-like conditions
Section 51727-6

Inactive ingredients: ethylparaben, glyceryl monostearate, polysorbate 80, purified water, sorbitan monooleate, stearic acid

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Uses

Temporarily relieves the minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Section 55106-9

Active ingredients                                                                             Purpose

Camphor 4%.................................................................................Topical analgesic

Menthol 10%.................................................................................Topical analgesic

Methyl Salicylate 30%.....................................................................Topical analgesic


Structured Label Content

Indications and Usage (34067-9)

Directions

  • use only as directed
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor
Dosage and Administration (34068-7)

Distributed By:

Genomma Lab USA, Inc.

Houston, TX 77027

Made in China

Warnings and Precautions (34071-1)

Warnings

For external use only

Allergy alert

  • if prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
Section 44425-7 (44425-7)

Other information

  • Store between 20 o and 25 o C (68 o and 77 oF)
Section 50565-1 (50565-1)

Keep out of reach of children to avoid accidental ingestion.

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • redness is present or irritation or rash develops
  • conditions worsen or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
Section 50567-7 (50567-7)

When using this product

  • do not use otherwise than as directed
  • avoid contact with eyes or mucous membranes or rashes
  • do not bandage tightly
Section 50569-3 (50569-3)

Ask a doctor before use

if you have redness over the affected area

Section 50570-1 (50570-1)

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12years of age with arthritis-like conditions
Section 51727-6 (51727-6)

Inactive ingredients: ethylparaben, glyceryl monostearate, polysorbate 80, purified water, sorbitan monooleate, stearic acid

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Uses

Temporarily relieves the minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Section 55106-9 (55106-9)

Active ingredients                                                                             Purpose

Camphor 4%.................................................................................Topical analgesic

Menthol 10%.................................................................................Topical analgesic

Methyl Salicylate 30%.....................................................................Topical analgesic


Advanced Ingredient Data


Raw Label Data

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