Drug Facts

Active Ingredients:

Methyl Salicylate 15.0%

Menthol 10.0%

Purpose:

Topical Analgesic

Uses:

For the temporarily relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • and sprains.

Warnings:

For external use only. If you had prior allergic reaction to aspirin or salicylate, please consult a physician before use. Allergy Alert:

Do not use

• on wounds or damaged skin • with a heating pad. you have redness over the affected area. Ask a Physician before use if

When using this product

• avoid contact with eyes and mucus membranes • do not bandage tightly.

Stop use and ask a physician if

• condition worsens or symptoms persist for more than 7 days • symptoms clear up and occur again within a few days • excessive skin irritation occur • pregnant or breastfeeding.

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Centre right away.

Directions:

Use only as directed • 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 physician.

Other information:

Store at 20 °C to 25 °C (68 °F - 77 °F).

Inactive Ingredients:

Acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis (aloe vera gel) juice, aqua (deionized water), arnica montana (arnica) extract, camellia sinensis (green tea) leaf extract, citrus aurantium dulcis (orange) peel oil, citrus medica limonum (lemon) extract, ethylhexylglycerin, helianthus annuus (sunflower) seed oil, isopropyl myristate, PEG-8, phenoxyethanol, pyridoxine (vitamin B6), sodium lauryl sulfate, triethanolamine.

Package Labeling:

label

VELATRIN PAIN RELIEF
methyl salicylate, menthol, unspecified form cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70287-716
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	15 mg in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA (UNII: O80TY208ZW)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ORANGE OIL (UNII: AKN3KSD11B)
LEMON (UNII: 24RS0A988O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PYRIDOXINE (UNII: KV2JZ1BI6Z)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70287-716-01	113 g in 1 JAR; Type 0: Not a Combination Product	02/09/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	11/25/2015

Labeler - Quality Nature, Inc. (080014569)

Velatrin Pain Relief Cream