CIRLUTONE- camphor ointment 
Herbal Health LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Camphor 0.6%

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

For the temporary relief of pain associated with:

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.

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

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

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

Exp. Date:

Lot No.:

Manufactured by:

Neutraderm, Inc.

20660 Nordhoff St.

Chatsworth, CA. 91311

info@cirlutone.com

www.cirlutone.com

CIRLUTONE

Ointment

Topical Analgesic

Net Wt. 3.53oz/100g.

CirlutoneCarton

CIRLUTONE 
camphor ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71917-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71917-001-35100 g in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/06/2017
Labeler - Herbal Health LLC (080764759)
Establishment
NameAddressID/FEIBusiness Operations
Neutraderm, Inc.146224444manufacture(71917-001)

Revised: 12/2017
Document Id: d60993ab-eae6-4307-9318-69c3449f3a53
Set id: 5b114844-1cb8-4e2c-961c-d9b91b8589f4
Version: 1
Effective Time: 20171206
 
Herbal Health LLC