SPL v1
SPL
SPL Set ID 78357755-255f-1030-e053-2991aa0aaa04
Route
TOPICAL
Published
Effective Date 2017-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (3.1 g)
Inactive Ingredients
Aloe Vera Leaf Orange Oil Lemon Oil Eucalyptus Oil Mentha Arvensis Flower Oil Rosemary Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-12-01

Description

Camphor 3.1%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Dosage and Administration
  • adults and children 2 yrs of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 yrs of age: consult a physician
Description

Distributed by Solaire Nutraceuticals

16 W. Madison St. Baltimore, MD 21202

solairenutraceuticals.com

4O4SO24PN

Section 50565-1

Keep out of reach of children. If swalled get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop And Ask Doctor If

  • condition worsens
  • symptoms last more than 7 days
  • symptoms clear up and com back in a few days
Section 50567-7

When Using This Product

  • use only as directed.
  • do not bandage tightly.
  • avoid contact with eyes or mucous membranes.
Section 50570-1

Do Not Use

  • for arthritis-like conditions in children under 2.
  • on wounds, damaged, broken or irritated skin
Section 51727-6

Aloe Barbadensis Leaf Juice, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Eucalyptus Globulus Leaf Oil, Mentha arvensis (Peppermint) Oil, Rosmarinus Officinalis Leaf (Rosemary) Oil

Section 51945-4

SOLAIRE

NUTRACEUTICALS

EASY JOINT TM

Pain Relief Spray

Spray Bottle

1f.l oz (30 mL)

Section 53413-1

(855) 303-2430

solairenutraceuticals.com

Section 53414-9

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

Section 55105-1

Camphor 3.1%.........................................Topical analgesic

Section 55106-9

Camphor 3.1%


Structured Label Content

Indications and Usage (34067-9)

temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Dosage and Administration (34068-7)
  • adults and children 2 yrs of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 yrs of age: consult a physician
Warnings and Precautions (34071-1)

For external use only.

Description (34089-3)

Distributed by Solaire Nutraceuticals

16 W. Madison St. Baltimore, MD 21202

solairenutraceuticals.com

4O4SO24PN

Section 50565-1 (50565-1)

Keep out of reach of children. If swalled get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop And Ask Doctor If

  • condition worsens
  • symptoms last more than 7 days
  • symptoms clear up and com back in a few days
Section 50567-7 (50567-7)

When Using This Product

  • use only as directed.
  • do not bandage tightly.
  • avoid contact with eyes or mucous membranes.
Section 50570-1 (50570-1)

Do Not Use

  • for arthritis-like conditions in children under 2.
  • on wounds, damaged, broken or irritated skin
Section 51727-6 (51727-6)

Aloe Barbadensis Leaf Juice, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Eucalyptus Globulus Leaf Oil, Mentha arvensis (Peppermint) Oil, Rosmarinus Officinalis Leaf (Rosemary) Oil

Section 51945-4 (51945-4)

SOLAIRE

NUTRACEUTICALS

EASY JOINT TM

Pain Relief Spray

Spray Bottle

1f.l oz (30 mL)

Section 53413-1 (53413-1)

(855) 303-2430

solairenutraceuticals.com

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Camphor 3.1%.........................................Topical analgesic

Section 55106-9 (55106-9)

Camphor 3.1%


Advanced Ingredient Data


Raw Label Data

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