Label: ASPERCREME WITH LIDOCAINE DRY- lidocaine spray
- NDC Code(s): 41167-0583-5
- Packager: Chattem, Inc.
- 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.
Updated June 9, 2021
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- SPL UNCLASSIFIED SECTION
- Active ingredient
For external use only
Do not use
■ on large areas of the body or on cut, irritated or swollen skin
■ on puncture wounds
■ for more than one week without consulting a doctor
When using this product
■ use only as directed. Read and follow all directions and warnings on this label.
■ do not allow contact with the eyes and mucous membranes
■ avoid spraying on face
■ avoid inhalation of spray
■ do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use
■ do not use at the same time as other topical analgesics
Stop use and ask a doctor if
■ condition worsens
■ redness is present
■ irritation develops
■ symptoms persist for more than 7 days or clear up and occur again within a few days
■ do not use near heat or flame or while smoking
■ avoid long term storage above 104°F (40°C)
■ do not puncture or incinerate. Contents under pressure.
■ do not store at temperatures above 120°F (49°C)
- Inactive ingredients:
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ASPERCREME WITH LIDOCAINE DRY
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0583 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ISOBUTANE (UNII: BXR49TP611) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0583-5 113 mL in 1 CAN; Type 0: Not a Combination Product 01/02/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/02/2019 Labeler - Chattem, Inc. (003336013)