COLD AND HEAT PAIN RELIEVING CREAM- menthol and methyl salicylate cream

Cold and Heat Pain Relieving Cream by

Drug Labeling and Warnings

Cold and Heat Pain Relieving Cream by is a Otc medication manufactured, distributed, or labeled by SOTAC PHARMACEUTICALS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Menthol 10%

Methyl salicylate 30%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

• arthritis
  
• simple backache
  
• muscle strains
  
• sprains
  
• bruises
  
• cramps

Warnings

For external use only

SEE INSIDE LABEL FOR COMPLETE DRUG FACTS

Allergy Alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

When using this product

• use only as directed
  
• do not bandage tightly or use with a heating pad
  
• avoid contact with eyes or mucous membranes
  
• do not apply to wounds or damaged, broken or irritated skin

Stop use and ask a doctor if

• condition worsens
  
• redness is present
  
• irritation develops
  
• symptoms persist for more than 7 days or clear up and occur again 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 Center right away.

Directions

adults and children over 12 years:

• apply generously to affected area
  
• massage into painful area until thoroughly absorbed into skin
  
• repeat as necessary, but not more than 4 times daily

children 12 years or younger: ask a doctor

Inactive ingredients

ceresin, cyclomethicone, hydrogenated castor oil, microcrystalline wax, paraffin, PEG-150 distearate, propylene glycol, stearic acid, stearyl alcohol (245-111)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COLD AND HEAT PAIN RELIEVING CREAM 
menthol and methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72351-010
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	30 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ESTERS WAX (UNII: D072FFP9GU)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72351-010-00	208 g in 1 BOX; Type 0: Not a Combination Product	08/09/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/09/2018

Labeler - SOTAC PHARMACEUTICALS PRIVATE LIMITED (876894019)