MUSCLE RUB- menthol, methyl salicylate cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Menthol 10%, Methyl salicylate 15%
Available from:
NuCare Pharmaceuticals,Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Topical analgesic temporarily relieves the minor aches and pains of muscles and joints associated with - simple backache - arthritis - strains - bruises - sprains
Authorization status:
OTC monograph not final
Authorization number:
68071-1617-3

MUSCLE RUB- menthol, methyl salicylate cream

NuCare Pharmaceuticals,Inc.

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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Perrigo Muscle Rub Drug Facts

Active ingredients

Menthol 10%

Methyl salicylate 15%

Purpos e

Topical analgesic

Us es

temporarily relieves the minor aches and pains of muscles and joints associated with

simple backache

arthritis

strains

bruises

sprains

Warnings

For external use only

Do not use

other than as directed

on children under 12 years of age

with a heating pad (may blister skin)

When using this product

avoid contact with the eyes or mucous membranes

do not apply to wounds or damaged skin

do not bandage tightly

Stop use and ask a doctor if

skin redness or excessive irritation of the skin develops

condition worsens or symptoms persist for more than 7 days

symptoms clear up and occur again within a few days

Keep out of reach of children

to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right

away.

Directions

adults & children 12 years of age and older: apply to affected area not more than 3 to 4 times daily

children under 12 years of age: consult a physician

Other information

store at 20°-25°C (68°-77°F)

Lot No. & Exp. Date, see crimp of tube and see box

Inactive ingredients

citric acid, glyceryl monostearate, lanolin, methylparaben, propylene glycol, propylparaben, purified

water, stearic acid, trolamine

Questions or comments?

1-800-719-9260

Principal Display Panel

MUSCLE RUB

menthol, methyl salicylate cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 0 71-16 17(NDC:458 0 2-174)

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

10 g in 10 0 g

METHYL SALICYLATE (UNII: LAV5U50 22Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

METHYL SALICYLATE

15 g in 10 0 g

NuCare Pharmaceuticals,Inc.

Inactive Ingredients

Ingredient Name

Stre ng th

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

LANO LIN (UNII: 7EV6 5EAW6 H)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

WATER (UNII: 0 59 QF0 KO0 R)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 0 71-16 17-3

8 5 g in 1 BOX; Type 0 : No t a Co mbinatio n Pro duct

0 7/26 /20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 3/0 3/20 11

Labeler -

NuCare Pharmaceuticals,Inc. (010632300)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

NuCare pharmaceuticals,Inc.

0 10 6 3230 0

re la be l(6 8 0 71-16 17)

Revised: 10/2019

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