RAMEDICA- ramedica ointment 
Ramedicare Sdn. Bhd.

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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Active Ingredients

Camphor

Wintergreen Oil (Methyl Salicylate)

Eucalyptus Oil

Menthol

Purpose

Topical Analgesic

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center immediately.

Inactive Ingredients

Borneol

Cassia Oil

Clove Oil

Cinnamon Leaf Oil

Citronella Oil

Nutmeg Oil

Petrolatum USP

Directions

For adults and children over 12, rub well on the affected area. Repeat 3 to 4 times daily

For children 12 years of age or younger, consult a doctor before use.

Warnings

For external use only. This product may cause allergic reaction in some individuals. Test on small area before use.

Uses

For temporary relief of the minor aches and pains in muscles and joints related to rheumatism, arthritis, backaches, strains, sprains, sports and other minor injuries.

Container Label

Image of Container Label

RAMEDICA 
ramedica ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66059-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)2.53 g  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE2.30 g  in 1 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL2.30 g  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.84 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
BORNEOL (UNII: M89NIB437X) 1 g  in 1 g
PADANG CASSIA OIL (UNII: 0E15252LIW) 1 g  in 1 g
CLOVE OIL (UNII: 578389D6D0) 1 g  in 1 g
CINNAMON LEAF OIL (UNII: S92U8SQ71V) 1 g  in 1 g
CITRONELLA OIL (UNII: QYO8Q067D0) 1 g  in 1 g
NUTMEG OIL (UNII: Z1CLM48948) 1 g  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) 8.03 g  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66059-0001-123 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/13/2000
Labeler - Ramedicare Sdn. Bhd. (894194026)
Registrant - Ramedicare Sdn. Bhd. (894194026)
Establishment
NameAddressID/FEIBusiness Operations
Ramedicare Sdn. Bhd.894194026manufacture(66059-0001)

Revised: 2/2014
Document Id: d521df41-f102-4176-acc5-91dda4f437a5
Set id: 08c2d823-e8c6-4971-9fd1-2486f7e009d4
Version: 1
Effective Time: 20140220
 
Ramedicare Sdn. Bhd.