SPL v1
SPL
SPL Set ID 6611b273-0cde-052d-e053-2991aa0a6996
Route
TOPICAL
Published
Effective Date 2018-02-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-02-19

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 years of age and older: apply to (gently wipe) affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a physician
Description

Distributed by

O24 TM Naturals, LLC

306 Hallmark Dr.,

Arlington, TX 76011

Questions?

Call TOLL-FREE:

1.866.902.8594 or visit us at:

www.O24zone.com

O24 TM is a Registered Trademark

of O24 TM Naturals, LLC.

Section 50565-1

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

Section 50566-9

Stop Use and Ask Doctor If

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

When Using This Product

  • use only as directed.
  • do not bandage tightly.
  • avoid contact with the eyes and 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 Leaf) Oil, Rosmarinus Ofcinalis Leaf (Rosemary) Oil

Section 51945-4

024 TM Naturals

024 TM

Pain Neutralizer

Topical Analgesic

Penetrating Pain Relief

for the temporary relieft of minor aches & pains associated with arthritis, strains, backaches, and bruises

10 Towelettes

(4 in x 6 in / 10.2 cm x 15.2 cm)

Section 53414-9

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

Section 55105-1

Camphor 3.1%.............................External 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 years of age and older: apply to (gently wipe) affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a physician
Warnings and Precautions (34071-1)

For External Use Only.

Description (34089-3)

Distributed by

O24 TM Naturals, LLC

306 Hallmark Dr.,

Arlington, TX 76011

Questions?

Call TOLL-FREE:

1.866.902.8594 or visit us at:

www.O24zone.com

O24 TM is a Registered Trademark

of O24 TM Naturals, LLC.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop Use and Ask Doctor If

  • condition worsens
  • symptoms last more than 7 days
  • symptoms clear up and come 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 the eyes and 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 Leaf) Oil, Rosmarinus Ofcinalis Leaf (Rosemary) Oil

Section 51945-4 (51945-4)

024 TM Naturals

024 TM

Pain Neutralizer

Topical Analgesic

Penetrating Pain Relief

for the temporary relieft of minor aches & pains associated with arthritis, strains, backaches, and bruises

10 Towelettes

(4 in x 6 in / 10.2 cm x 15.2 cm)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Camphor 3.1%.............................External Analgesic

Section 55106-9 (55106-9)

Camphor 3.1%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)