SPL v1
SPL
SPL Set ID 5b114844-1cb8-4e2c-961c-d9b91b8589f4
Route
TOPICAL
Published
Effective Date 2017-12-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (0.6 g)
Inactive Ingredients
Angelica Anomala Whole White Wax Frankincense Oil Isopropyl Alcohol Ligusticum Wallichii Whole Magnolia Liliiflora Whole Methylparaben Mineral Oil Petrolatum Propylparaben Water Sophora Flavescens Whole Syzygium Aromaticum Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-12-06

Description

Camphor 0.6%


Medication Information

Warnings and Precautions

For External Use only.

Flammable: keep away from fire or flame

Indications and Usage

For the temporary relief of pain associated with:

  • sunburn
  • minor cuts
  • scrapes
Dosage and Administration
  • Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
  • Children under 2 yrs of age: consult a doctor.
Description

Herbal Health L.L.C.

Made in the U.S.A.

www.cirlutone.com

Section 44425-7
  • Store in a cool & dry place
  • Do not use if tamper evident seal is broken or missing
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 50566-9

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
Section 50567-7

When using this product

  • avoid contact with eyes or mucous membrane
  • use only as directed
Section 51727-6

Angelica anemala, Emulsifying Wax NF, Fragrance, Frankincense Oil, Isopropyl alcohol, Ligusticum wallichii, Magnolia liliflora, Methylparaben, Mineral Oil, Petrolatum, Propylparaben, Purified Water, Sophora, Syzgium armaticum

Section 51945-4

CIRLUTONE

Ointment

Topical Analgesic

Net Wt. 3.53oz/100g.

Section 53413-1

Call 310-888-8878 Monday through Friday, 9am-5pm CST.

Section 53414-9

If pregnant or breastfeeding, ask a healthcare professional before use.

Section 55105-1

Camphor 0.6%...............Topical Analgesic

Section 55106-9

Camphor 0.6%


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of pain associated with:

  • sunburn
  • minor cuts
  • scrapes
Dosage and Administration (34068-7)
  • Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
  • Children under 2 yrs of age: consult a doctor.
Warnings and Precautions (34071-1)

For External Use only.

Flammable: keep away from fire or flame

Description (34089-3)

Herbal Health L.L.C.

Made in the U.S.A.

www.cirlutone.com

Section 44425-7 (44425-7)
  • Store in a cool & dry place
  • Do not use if tamper evident seal is broken or missing
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • condition worsens
  • 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

  • avoid contact with eyes or mucous membrane
  • use only as directed
Section 51727-6 (51727-6)

Angelica anemala, Emulsifying Wax NF, Fragrance, Frankincense Oil, Isopropyl alcohol, Ligusticum wallichii, Magnolia liliflora, Methylparaben, Mineral Oil, Petrolatum, Propylparaben, Purified Water, Sophora, Syzgium armaticum

Section 51945-4 (51945-4)

CIRLUTONE

Ointment

Topical Analgesic

Net Wt. 3.53oz/100g.

Section 53413-1 (53413-1)

Call 310-888-8878 Monday through Friday, 9am-5pm CST.

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a healthcare professional before use.

Section 55105-1 (55105-1)

Camphor 0.6%...............Topical Analgesic

Section 55106-9 (55106-9)

Camphor 0.6%


Advanced Ingredient Data


Raw Label Data

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