ASPER-FLEX CREAM- trolamine salicylate cream

Asper-Flex by

Drug Labeling and Warnings

Asper-Flex by is a Otc medication manufactured, distributed, or labeled by Geritrex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients...................................Purpose
Trolamine Salicylate(10%).......................Topical Analgesic

Uses

For the temporary relief of minor aches and pains of
muscles and joints associated with arthritis, simple backaches,
strains and sprains.

Directions

Apply generously to affected area. Massage
into painful area until thoroughly absorbed into skin.
Repeat as necessary, but not more than 4 times daily.

DOSAGE & ADMINISTRATION

No more than 4 times daily.

Warnings

Use only as directed If prone to allergic
reaction from aspirin or salicylate, consult a doctor If redness
is present, discontinue use and consult a doctor If
condition worsens or if pain persists for more than 7 days
or clears up and occurs again within a few days, discontinue
use and consult a doctor Avoid contact with eyes As
with any drug, if you are pregnant or nursing a baby, seek
the advice of a health professional before using this product
Do not use: On children under 10 years of age If
skin is irritated or if irritation develops KEEP THIS AND
ALL MEDICINE OUT OF THE REACH OF CHILDREN In
case of accidental ingestion, seek professional assistance or
contact a poison control center immediately

Other Ingredients

Aloe Vera Gel, Alpha Tocopherol, Cetyl Alcohol, Glycerin, DMDM Hydantoin, Methylparaben, Mineral Oil, Propylene Glycol, Propylparaben, Stearic Acid, Triethanolamine, Water  

Storage

At room temperature 15º-30º C (59º-86º F).
Close cap tightly after use.

Keep out of reach of children

KEEP THIS AND ALL MEDICINE OUT OF THE REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASPER-FLEX   CREAM
trolamine salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54162-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Trolamine Salicylate (UNII: H8O4040BHD) (salicylic acid - UNII:O414PZ4LPZ)	Trolamine Salicylate	8.5 g  in 85 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
DMDM HYDANTOIN (UNII: BYR0546TOW)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54162-010-03	85 g in 1 TUBE; Type 0: Not a Combination Product	07/31/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/31/2015

Labeler - Geritrex LLC (112796248)

Establishment
Name	Address	ID/FEI	Business Operations
Geritrex LLC		112796248	manufacture(54162-010)