Label: TUCKS MEDICATED COOLING PADS- witch hazel solution
- NDC Code(s): 10157-2103-1, 10157-2103-2, 10157-2103-3, 10157-2103-4
- Packager: Blistex 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.
Drug Label Information
Updated December 15, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
-
Warnings
For external use only.
When using this product
- do not use more than directed unless told to do so by a doctor
- do not put directly in the rectum by using fingers or any mechanical device or applicator
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Directions
Adults:
- when practical, clean the affected area with mild soap and warm water, and rinse thoroughly
- gently dry by patting or blotting with toilet tissue or a soft cloth before applying
- apply externally to the affected area up to 6 times daily or after each bowel movement
- after application, discard pad and wash hands
Children under 12 years of age: ask a doctor
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL - 100 Pad Jar Carton
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INGREDIENTS AND APPEARANCE
TUCKS MEDICATED COOLING PADS
witch hazel solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10157-2103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL 500 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) EDETATE DISODIUM (UNII: 7FLD91C86K) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10157-2103-2 1 in 1 CARTON 08/30/2016 1 100 in 1 JAR 1 1 mL in 1 APPLICATOR; Type 0: Not a Combination Product 2 NDC:10157-2103-1 1 in 1 CARTON 08/30/2016 2 40 in 1 JAR 2 1 mL in 1 APPLICATOR; Type 0: Not a Combination Product 3 NDC:10157-2103-3 40 in 1 JAR 08/30/2016 3 1 mL in 1 APPLICATOR; Type 0: Not a Combination Product 4 NDC:10157-2103-4 2 in 1 CARTON 08/30/2016 4 100 in 1 JAR 4 1 mL in 1 APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 08/30/2016 Labeler - Blistex Inc (005126354) Establishment Name Address ID/FEI Business Operations Blistex Inc 005126354 manufacture(10157-2103)