ALGOMEND PAIN RELIEF- menthol cream

ALGOMEND Pain Relief by

Drug Labeling and Warnings

ALGOMEND Pain Relief by is a Otc medication manufactured, distributed, or labeled by Cytosome LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Menthol             2.00%

PURPOSE

External Analgesic

USE

For temporary relief of minor muscle and joint aches and pains associated with arthritis, simple backache, bruises, strains and sprains.

WARNINGS:

For external use only. Avoid contact with eyes. Do not apply to open wounds or damaged skin. Do not bandage tightly.

Keep out of reach of children.

If swallowed, consult physician.

STOP USE

If symptoms persist for more than seven days, discontinue use and consult physician.

ASK DOCTOR

If pregnant or breast feeding, contact physcian prior to use.

Directions:

Apply directly to effected area. Do not use more than four times per day.

OTHER INGREDIENTS

Aqua (Deionized Water), BUTYROSPERMUM PARKII (SHEA) BUTTER, CAMPHOR, CARBOMER, DIAZOLIDINYL UREA, Emulsifying Wax NF, EUCALYPTUS GLOBULUS LEAF OIL, Glyceryl Sterate, HELIANTHUS ANNUUS (SUNFLOWER) Oil, PEG-100 STERATE, POLYSORBATE-20, TRIETHANOLAMINE.

SPL UNCLASSIFIED SECTION

Distributed by:

Cytosome LLC, Conyers, GA 30013

Contact@algomend.comwww.algomend.com

Package Label

ALGOMEND

Pain Relief to Help Keep You Moving

• Relieves stiffness and minor muscle & joint pain
• Non-greasy, quickly absorbed formula
• Paraben free

2 fl oz. / 59 ml

INGREDIENTS AND APPEARANCE

ALGOMEND PAIN RELIEF 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69544-152
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
FRANKINCENSE OIL (UNII: 67ZYA5T02K)
CARBOMER 1342 (UNII: 809Y72KV36)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCINE (UNII: TE7660XO1C)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CHOLINE CHLORIDE (UNII: 45I14D8O27)
PROLINE (UNII: 9DLQ4CIU6V)
LYSINE (UNII: K3Z4F929H6)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
MALIC ACID (UNII: 817L1N4CKP)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SORBITAN OLIVATE (UNII: MDL271E3GR)
ROSA CANINA FLOWER OIL (UNII: DUY7M48I1T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
PROPANEDIOL (UNII: 5965N8W85T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69544-152-01	59 mL in 1 JAR; Type 0: Not a Combination Product	01/21/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/21/2015

Labeler - Cytosome LLC (009058190)