WHITE FLOWER STRAIN RELIEF - camphor, menthol and methyl salicylate oil 
JELMA PHILIPPINES INC

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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Drug Facts

Active ingredients
Camphor 10%
Menthol 15%
Methyl Salicylate 50%

Purpose
External Analgesic

Uses
Tempoarily relieves minor aches and pains of muscles and joints due to:
■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Warnings
For external use only

Do not use
■ on wounds
■ on irritated or damaged skin
■ otherwise than as directed

When using this product
■ avoid contact with the eyes or mucous membranes
■ do not bandage tightly

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
■ excessive irritation develops
■ nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
■ when using for pain of arthritis:
    ■ pain persists for more than 10 days
    ■ redness is present
    ■ in conditions affecting children under 12 years of age

Keep out of reach of children to avoid accidental poisoning.
If swallowed, get medical help or contact a Poison Control Center right away.

Directions
■ adults and children 3 years of age and older: apply on the affected area not more than 3 to 4 times daily.
After applying the product, a warm pad may be placed on the affected area for 10 minutes and then massage gently.
■ children under 3 years of age: do not use, consult your physician
■ refer to the above warnings; use otherwise than as directed may be dangerous

Other information
■ store at 15º to 30º C (59º to 86º F)
■ keep container tightly closed

Inactive ingredients
Beta carotene, Cassia oil, D C Green No. 6, D C Red No. 17, Eucalyptus oil, Fragrance, Lavender oil, Mineral oil.

Questions or comments?
(888) 221-3496 M-F 9 am to 5 pm

WHITE FLOWER STRAIN RELIEF PAIN RELIEVING OIL  NDC 48256-0041-1  1.7 FL OZ (50 ML)IMAGE OF CARTON 50ML

WHITE FLOWER STRAIN RELIEF 
camphor, menthol and methyl salicylate oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51681-0041
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)10 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL15 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE50 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BETA CAROTENE (UNII: 01YAE03M7J)  
CHINESE CINNAMON OIL (UNII: A4WO0626T5)  
D&C GREEN NO. 6 (UNII: 4QP5U84YF7)  
D&C RED NO. 17 (UNII: ND733RX3JN)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51681-0041-150 mL in 1 BOTTLE, GLASS
2NDC:51681-0041-225 mL in 1 BOTTLE, GLASS
3NDC:51681-0041-33 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/20/2012
Labeler - JELMA PHILIPPINES INC (721085447)
Establishment
NameAddressID/FEIBusiness Operations
JELMA PHILIPPINES INC721085447repack
Establishment
NameAddressID/FEIBusiness Operations
HOE HIN PAK FAH YEOW MANUFACTORY LTD686359001manufacture

Revised: 2/2012
Document Id: ac4655a0-6c2f-4cbd-ad49-9c57c85e7798
Set id: c0d347eb-eab0-4132-874b-0d162b3fe12c
Version: 1
Effective Time: 20120220
 
JELMA PHILIPPINES INC