RAMEDICA by Ramedicare Sdn. Bhd. RAMEDICA ointment

RAMEDICA by

Drug Labeling and Warnings

RAMEDICA by is a Otc medication manufactured, distributed, or labeled by Ramedicare Sdn. Bhd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

RAMEDICA 
ramedica ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66059-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	12 g  in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	7 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	11 g  in 100 g
PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B)	PEPPERMINT OIL	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66059-0002-1	23 g in 1 BOTTLE; Type 0: Not a Combination Product	01/23/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/23/2018

Labeler - Ramedicare Sdn. Bhd. (894194026)

Registrant - Ramedicare Sdn. Bhd. (894194026)