Drug Labeling and Warnings

Drug Details

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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

Eucalyptus Oil

Menthol

Peppermint oil

Purpose

Topical Analgesic

Keep Out Of Reach Of Children

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

Inactive Ingredients

Borneol 1%
Cassia Oil 1%
Cinnamon Leaf Oil 6%
Citronella Oil 6%
Clove Oil, Nutmeg Oil 6%
Paraffin Wax 17%
Petroleum Jelly 21%

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.

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

WARNINGS: For external use only. When using this product: Discontinue use if excessive irritation of the skin develops. Avoid contact with eyes and mucus membranes. Do not bandage tightly. Do not use with heating pad.

Stop use and ask a doctor if:
▪ Condition worsens. ▪ Severe skin irritation occurs. ▪ Pain persists for more than seven days. ▪ Pain clears up and the recurs within a few days.

If pregnant or breast-feeding, ask a health care professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control immediately.

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

Product label

RAMEDICA 
ramedica ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 66059-0002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)12 g  in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL7 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL11 g  in 100 g
PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BORNEOL (UNII: M89NIB437X)  
PADANG CASSIA OIL (UNII: 0E15252LIW)  
CLOVE OIL (UNII: 578389D6D0)  
CINNAMON LEAF OIL (UNII: S92U8SQ71V)  
CITRONELLA OIL (UNII: QYO8Q067D0)  
NUTMEG OIL (UNII: Z1CLM48948)  
PETROLATUM (UNII: 4T6H12BN9U)  
PARAFFIN (UNII: I9O0E3H2ZE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 66059-0002-123 g in 1 BOTTLE; Type 0: Not a Combination Product01/23/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/23/2018
Labeler - Ramedicare Sdn. Bhd. (894194026)
Registrant - Ramedicare Sdn. Bhd. (894194026)

Revised: 1/2018
 
Ramedicare Sdn. Bhd.


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