HYSAN PAIN RELIEVER (methyl salicylate, menthol, camphor- synthetic, eucalyptus oil oil

HYSAN PAIN RELIEVER by

Drug Labeling and Warnings

HYSAN PAIN RELIEVER 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

ACTIVE INGREDIENT:

METHYL SALICYLATE 37%

MENTHOL 36%

CAMPHOR 10%

EUCALYPTUS OIL 10%

PURPOSE

PURPOSE:

EXTERNAL ANALGESIC

INDICATIONS & USAGE

USES

TEMPORARILY RELIEVES MINOR ACHES, 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

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, APPLY TO AFFECTED AREA NOT MORE THAN 3 TO 4 TIMES DAILY.

CHILDREN UNDER 12 YEARS OF AGE CONSULT A DOCTOR BEFORE USING

PREGNANCY OR BREAST FEEDING

PREGNANT OR NURING A BABY CONSULT A DOCTOR BEFORE USING

INACTIVE INGREDIENT

INACTIVE INGREDIENTS:

TURPENTINE OIL, SPIKE LAVENDER OIL, PERFUME OIL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYSAN PAIN RELIEVER 
methyl salicylate, menthol, camphor (synthetic), eucalyptus oil oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63255-021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	37 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	36 g  in 100 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	10 g  in 100 mL
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TURPENTINE OIL (UNII: C5H0QJ6V7F)
LAVENDER OIL (UNII: ZBP1YXW0H8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63255-021-02	3 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/20/2012	10/01/2020
2	NDC: 63255-021-01	40 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/20/2012	10/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/20/2012	10/01/2020

Labeler - HYSAN PHARMACEUTICAL CO LTD (666427133)

Establishment
Name	Address	ID/FEI	Business Operations
HYSAN PHARMACEUTICAL CO LTD		666427133	manufacture(63255-021)