Non-Greasy Pain Relieving Cream (Muscle Rub)

Pain Relieving by

Drug Labeling and Warnings

Pain Relieving by is a Otc medication manufactured, distributed, or labeled by BluePoint Laboratories, Gopaldas Visram & Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PAIN RELIEVING- pain relieving cream 
BluePoint Laboratories

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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Non-Greasy Pain Relieving Cream (Muscle Rub)

Drug Facts

Active Ingredient(s)

Menthol 10%

Methyl Salicylate 15%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

For external use only

Do not use on

wounds or damaged skin

When using this product

• avoid contact with eyes
• do not bandage tightly

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

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

Directions

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
• Children under 2 years of age: Consult a doctor

Other Information

• Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal
• Store at room temperature
• See Crimp of tube or carton for Lot Number and Expiry Date

Inactive ingredients

Allantoin, Carbopol Ultrez 10, Cetyl Alcohol, Dimethicone 350, Edetate Disodium, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Methyl Paraben, Phenoxyethanol, Potassium Cetyl Phosphate, Propyl Paraben, Purified Water, Sodium Hydroxide, Stearic Acid, Titanium Dioxide, Tween 20, Vitamin E, Xanthan Gum

Questions?

Contact 1-800-707-4621

Manufactured in India by:

Gopaldas Visram & Company Limited

Plot No. A327, T.T.C Indl. Area, M.I.D.C

Mahape, Navi Mumbai - 400710.

Mfg. Lic. No.: KD/739

For BluePoint Laboratories

Rev 04/2022

Package Label - Principal Display Panel

Non-Greasy Pain Relieving (Muscle Rub) (Tube)

NDC: 68001-479-45

Non-Greasy Pain Relieving (Muscle Rub) (Carton)

NDC: 68001-479-45

PAIN RELIEVING 
pain relieving cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68001-479
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALLANTOIN (UNII: 344S277G0Z)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
DIMETHICONE 350 (UNII: 2Y53S6ATLU)
CETYL ALCOHOL (UNII: 936JST6JCN)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68001-479-45	1 in 1 CARTON	05/05/2022	05/06/2022
1		85.05 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/05/2022	05/06/2022

Labeler - BluePoint Laboratories (985523874)

Establishment
Name	Address	ID/FEI	Business Operations
Gopaldas Visram & Co., Ltd		858030888	manufacture(68001-479)

Revised: 9/2023

Document Id: 043b7fd2-ba0b-941f-e063-6394a90a827c

34390-5

Set id: dc73db77-ab49-49fa-e053-2995a90ae501

Version: 2

Effective Time: 20230904