Label: ASPER-FLEX CREAM- trolamine salicylate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 54162-010-03 - Packager: Geritrex LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated September 11, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Uses
- Directions
- DOSAGE & ADMINISTRATION
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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
- Storage
- Keep out of reach of children
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ASPER-FLEX CREAM
trolamine salicylate creamProduct 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)