Label: SHOPKO MEDICATED COOLING- witch hazel swab
-
Contains inactivated NDC Code(s)
NDC Code(s): 37012-211-00 - Packager: Shopko Stores Operating Co., LLC.
- 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 February 1, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- If pregnant or breast-feeding
-
Directions
- adult: cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area.
- use up to 6 times daily or after each bowel movement and before applying hemorrhoidal treatments, and then discard
- children under 12 years of age: consult a doctor
- Dispose of pad in trash after use.Do not flush
-
Other information
- store at room temperature 15-300C (59-86°F)
- for vaginal care - cleanse the area by gently wiping, patting, or blotting. Repeat as needed.
- for use as moist compress - if necessary, first cleanse the area as previously described. Fold wipe to desired size and place in contact with tissue for a soothing and cooling effect. Leave in place for 15 minutes and repeat as needed.
- Inactive Ingredients
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
SHOPKO MEDICATED COOLING
witch hazel swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37012-211 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL 50 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM BENZOATE (UNII: OJ245FE5EU) ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37012-211-00 100 in 1 PACKAGE 05/09/2017 1 2.9 g in 1 PACKET; 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 05/09/2017 Labeler - Shopko Stores Operating Co., LLC. (023252638) Registrant - Shopko Stores Operating Co., LLC. (023252638) Establishment Name Address ID/FEI Business Operations PREMIER CARE INDUSTRIES, INC 858442403 manufacture(37012-211)
