Label: PERSONAL CLEANSING CLOTHS WITH DIMETHICONE- dimethicone swab
- NDC Code(s): 63517-122-21
- Packager: Cardinal Health, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 July 12, 2016
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- Drug Facts
- Active Ingredient
For external use only.
- Avoid contact with the eyes
and contact a physician if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.
Keep out of reach of children
If swallowed, get medical help or contact Poison Control Center right away.
Pull back label and remove wipes
• Thoroughly cleanse soiled area, using one wipe at a time
•Use as often as necessary
•Dispose of cloths in a waste receptacle
•Do not flush
• Wipes may be used at room temperature but if heating is desired, wipes may be warmed in a wipes warmer. Wipes should be warmed:
• in a single warming session at temperatures not exceeding 52°C (125°F) and
• for a maximum of 4 days. Discard wipes that have been:
• Exposed to warming temperatures exceeding 52C (125F); or
• Stored longer than 4 days within the warmer; or
• Been warmed, allowed to cool, and then re-warmed.
- Other Information:
- Inactive Ingredients:
- Package Labeling:
INGREDIENTS AND APPEARANCE
PERSONAL CLEANSING CLOTHS WITH DIMETHICONE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63517-122 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 32 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) PPG-15 STEARYL ETHER (UNII: 1II18XLS1L) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALOE VERA LEAF (UNII: ZY81Z83H0X) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63517-122-21 42 in 1 CARTON 07/08/2016 1 223 g in 1 PACKAGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 07/05/2016 Labeler - Cardinal Health, Inc. (097537435)