CORAL ANALGESIC (methyl salicylate, eucalyptus oil, menthol crystal, camphor- synthetic ointment

CORAL ANALGESIC by

Drug Labeling and Warnings

CORAL ANALGESIC by is a Otc medication manufactured, distributed, or labeled by HYSAN PHARMACEUTICAL CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active Ingredients

Methyl Salicylate 22%

Eucalyptus Oil 11%

Menthol 11%

Camphor 2%

PURPOSE

Purpose

External Analgesic

INDICATIONS & USAGE

Uses

Temporarily Relieves minor aches, pains of muscles and joint pains due to:

• simple backache
• arthritis
• strains
• sprains
• bruises

WARNINGS

Warnings

• external use only
• use only as directed

DO NOT USE

Do not use

• on opened wounds
• on damaged skin

WHEN USING

When using this product

• avoid contact with the eyes
• do not bandage tighly

STOP USE

Stop use and ask a doctor if

• a rash or irritation develops
• condition worsens
• symptoms persist for more than 7 days or clears up and occur again within a few days

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

• adults and children 12 years and older, clean and dry the affected area, apply and massage gently not more than 3 to 4 times daily
• children under 12 years of age, consult a doctor before using

INACTIVE INGREDIENT

Inactive ingredients

White Soft Paraffin, Paraffin, Fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CORAL ANALGESIC 
methyl salicylate, eucalyptus oil, menthol crystal, camphor (synthetic) ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63255-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	22 g  in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	11 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	11 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PARAFFIN (UNII: I9O0E3H2ZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63255-030-01	75 g in 1 JAR; Type 0: Not a Combination Product	12/01/2016	05/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/27/2014	05/31/2020

Labeler - HYSAN PHARMACEUTICAL CO LTD (666427133)

Establishment
Name	Address	ID/FEI	Business Operations
HYSAN PHARMACEUTICAL CO LTD		666427133	manufacture(63255-030)