Label: CLEANSE PURE- alcohol solution
- NDC Code(s): 77031-505-01, 77031-505-33
- Packager: Frozen Wheels, Llc
- Category: HUMAN OTC DRUG LABEL
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 June 5, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Use[s]
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Warnings
For external use only. Flammable.
Keep away from heat or flame.
Do not use
- In children less than 2 months of age.
- On open skin wounds.
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
- Directions
- Other Information
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
CLEANSE PURE
alcohol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77031-505 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) ALOE VERA LEAF (UNII: ZY81Z83H0X) TROLAMINE (UNII: 9O3K93S3TK) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77031-505-33 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/18/2020 2 NDC:77031-505-01 4000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/18/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/18/2020 Labeler - Frozen Wheels, Llc (069055731)