CIRLUTONE- camphor ointment

Cirlutone by

Drug Labeling and Warnings

Cirlutone by is a Otc medication manufactured, distributed, or labeled by Herbal Health LLC, Neutraderm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Camphor 0.6%

PURPOSE

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

INDICATIONS & USAGE

For the temporary relief of pain associated with:

• sunburn
• minor cuts
• scrapes

WARNINGS

For External Use only.

Flammable: keep away from fire or flame

When using this product

• avoid contact with eyes or mucous membrane
• use only as directed

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

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

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

DOSAGE & 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.

STORAGE AND HANDLING

• Store in a cool & dry place
• Do not use if tamper evident seal is broken or missing

INACTIVE INGREDIENT

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

QUESTIONS

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

DESCRIPTION

Herbal Health L.L.C.
Made in the U.S.A.
www.cirlutone.com

DESCRIPTION

Exp. Date:

Lot No.:

Manufactured by:

Neutraderm, Inc.

20660 Nordhoff St.

Chatsworth, CA. 91311

info@cirlutone.com

www.cirlutone.com

PRINCIPAL DISPLAY PANEL

CIRLUTONE

Ointment

Topical Analgesic

Net Wt. 3.53oz/100g.

INGREDIENTS AND APPEARANCE

CIRLUTONE 
camphor ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71917-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ANGELICA ANOMALA WHOLE (UNII: T1F4GB8MNL)
WHITE WAX (UNII: 7G1J5DA97F)
FRANKINCENSE OIL (UNII: 67ZYA5T02K)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LIGUSTICUM WALLICHII WHOLE (UNII: 8Y1N3NX2DW)
MAGNOLIA LILIIFLORA WHOLE (UNII: GDO2997SZZ)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SOPHORA FLAVESCENS WHOLE (UNII: X8KX602M5L)
SYZYGIUM AROMATICUM WHOLE (UNII: EY9MMA0P6Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71917-001-35	100 g in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/06/2017

Labeler - Herbal Health LLC (080764759)

Establishment
Name	Address	ID/FEI	Business Operations
Neutraderm, Inc.		146224444	manufacture(71917-001)