Label: NRL PURE DAILY HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 74083-010-01 - Packager: Gpompous Trading Co., Ltd.
- 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.
Drug Label Information
Updated April 8, 2020
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
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WARNINGS
Warnings:
1. Do not use on the following body parts. (Eyes and ears, inside the mouth, wide body parts, and damaged skin)
2. If the following symptoms appear, immediately stop using and consult a physician or pharmacist. (Hypersensitivity such as rash, erythema, itchiness, and edema / Skin irritation)
3. Only use externally (do not intake)
4. When using on a wide area or for a long period, be careful about inhaling vapor. (Massive or repeated intake of ethanol vapor can cause irritation of the mucous membrane or headache, limited to products containing ethanol.)
5. Repeated use on the same part can cause roughening of the skin by removing oiliness.
6. Do not use on seal rod, plaster cast, and pack as doing so can cause irritation.
7. Do not use this product like a pack for the anus or vagina as doing so can cause irritation or chemical burn.
8. Only use for intended purposes.
9. Avoid firearms and protect from the light.
10. Keep away from children. If swallowed by a child, visit a hospital immediately.
11. Storing this product in a different bottle can lead to accidents or degradation from misuse. Keep the product in its original bottle and firmly close the bottle.
12. Do not use expired sanitary aids. - KEEP OUT OF REACH OF CHILDREN
- Uses
- Directions
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NRL PURE DAILY HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74083-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 43.4 g in 70 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74083-010-01 70 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/01/2020 Labeler - Gpompous Trading Co., Ltd. (695886541) Registrant - Gpompous Trading Co., Ltd. (695886541) Establishment Name Address ID/FEI Business Operations Gpompous Trading Co., Ltd. 695886541 manufacture(74083-010)