ASPER-FLEX  CREAM- trolamine salicylate cream 
Geritrex LLC

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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Asper-Flex Cream

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.

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

image description

ASPER-FLEX   CREAM
trolamine salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Trolamine Salicylate (UNII: H8O4040BHD) (salicylic acid - UNII:O414PZ4LPZ) Trolamine Salicylate8.5 g  in 85 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-010-0385 g in 1 TUBE; Type 0: Not a Combination Product07/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/31/2015
Labeler - Geritrex LLC (112796248)
Establishment
NameAddressID/FEIBusiness Operations
Geritrex LLC112796248manufacture(54162-010)

Revised: 9/2017
Document Id: 3eb26aa8-ea5a-4509-8694-a5fd15006a36
Set id: 2accc387-0ebd-4c08-b809-8be23679150a
Version: 3
Effective Time: 20170911
 
Geritrex LLC