HAMMER WIPES: Package Insert and Label Information

HAMMER WIPES- benzalkonium chloride and didecyldimonium chloride swab
Zhejiang Ruolin Hygienic Products Co., Ltd.

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.

Active Ingredient

Benzalkonium Chloride 0.1%

Didecyldimonium Chloride 0.2%

Purpose

Antimicrobial

USE

Wipes for surface

Warning

  • For use on surfaces and to sanitize skin
  • Gentle on skin — contains aloe
  • No rinsing or wiping required
  • Nor should you use them on or near your eyes. if you gen any of the ingredients in your eye, remove any contacts and gently rinse the eye with water for as long as needed.
  • If ingested or if irritation persists, contact a poison control cnter for advice or seek medical attention.
  • these are wipes, not toilet paper……´╝îplease don’t flush them down toilets. Before using on unsealed surfaces or fabric, we recommend testing a small area for discoloration first. Don’t store or use these near heat sources or an open flame.

Storage:

Refrigerate after opening (just kidding), Just store these at room temperature. wali-in freezers, boiler rooms and things of that nature don’t count. just store them at regular “tank top to sweatshirt” room temperature. Tjis container is not designed for refiils, please do not reuse it for wipes. Also please recycle this container if possible. It’s really not that hard.

Children under 6 should be supervised when using wipes.

Directions

  • Apply wipe to surface and allow to dry
  • Children under 6 years of age should be supervised when using this product.

Inactive ingredients

Water, Glycerin, Ehtylhexylglycerin, Phenoxyethanol, Propylene Glycol

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HAMMER WIPES
benzalkonium chloride and didecyldimonium chloride swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:78823-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.10 g in 100 g
didecyldimonium chloride (DIDECYLDIMONIUM) didecyldimonium chloride 0.20 g in 100 g
Inactive Ingredients
Ingredient Name Strength
water
GLYCERIN
ETHYLHEXYLGLYCERIN
PHENOXYETHANOL
PROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:78823-001-01 70 POUCH in 1 CANISTER contains a POUCH
1 3.78 g in 1 POUCH This package is contained within the CANISTER (78823-001-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 06/24/2020
Labeler — Zhejiang Ruolin Hygienic Products Co., Ltd. (415426870)
Establishment
Name Address ID/FEI Operations
Zhejiang Ruolin Hygienic Products Co., Ltd. 415426870 manufacture (78823-001)

Revised: 06/2020 Zhejiang Ruolin Hygienic Products Co., Ltd.

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