Han-San Topical 80: Package Insert and Label Information

HAN-SAN TOPICAL 80- alcohol liquid
HAN-SAN GEL- alcohol gel
HAN-SAN TOPICAL- alcohol liquid
Rite-Kem Incorporated

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.

Alcohol 70%

Antiseptic

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

For external use only. Flammable. Keep away from heat or flame

  • In children less than 2 months of age
  • on open skin wounds

Stop use and ask a doctor if irritiation or rash occurs. These may be signs of serious condition

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions.

  • Place enough product on hands to cover all surfaces. Rub together until dry.
  • Suerpvise children under 6 years of age when using this product to avoid swallowing.

Other information

store between 15-30 c (59-86F)

Avoid freezing and excessing heat above 40 c (104F)

Inactive ingredients: glycerin, hydrogen peroxide, purified water USP

80
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san
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topical
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HAN-SAN TOPICAL 80
han-san topical 80 liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73943-947
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 80 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
HYDROGEN PEROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73943-947-01 946 mL in 1 BOTTLE None
2 NDC:73943-947-02 3785 mL in 1 BOTTLE None
3 NDC:73943-947-03 473 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/24/2020
HAN-SAN GEL
han-san gel gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73943-945
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
TROLAMINE
GLYCERIN
LAVANDULA ANGUSTIFOLIA FLOWER
ETHYL ACRYLATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73943-945-01 59.14 mL in 1 BOTTLE None
2 NDC:73943-945-02 1123.79 mL in 1 BOTTLE None
3 NDC:73943-945-03 3785.41 mL in 1 BOTTLE None
4 NDC:73943-945-04 473 mL in 1 BOTTLE None
5 NDC:73943-945-05 208198 mL in 1 BOTTLE None
6 NDC:73943-945-06 1040990 mL in 1 TANK None
7 NDC:73943-945-07 118.29 mL in 1 BOTTLE None
8 NDC:73943-945-08 354.9 mL in 1 BOTTLE None
9 NDC:73943-945-09 2000 mL in 1 BOTTLE None
10 NDC:73943-945-10 44 mL in 1 BOTTLE None
11 NDC:73943-945-11 592 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/24/2020
HAN-SAN TOPICAL
han-san topical liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73943-946
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
HYDROGEN PEROXIDE
LAVANDULA ANGUSTIFOLIA FLOWER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73943-946-01 946 mL in 1 BOTTLE None
2 NDC:73943-946-02 3785 mL in 1 BOTTLE None
3 NDC:73943-946-03 473 mL in 1 BOTTLE None
4 NDC:73943-946-04 208198 mL in 1 BOTTLE None
5 NDC:73943-946-05 1040990 mL in 1 TANK None
6 NDC:73943-946-06 18927 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/24/2020
Labeler — Rite-Kem Incorporated (786892927)
Establishment
Name Address ID/FEI Operations
Rite-Kem Incorporated 786892927 manufacture (73943-945), manufacture (73943-946), manufacture (73943-947)

Revised: 11/2020 Rite-Kem Incorporated

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