ACS GOLDEN TOUCH ANTISEPTIC HAND SANITIZER: Package Insert and Label Information

ACS GOLDEN TOUCH ANTISEPTIC HAND SANITIZER- alcohol gel
American Chemical Systems II, LLC

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 Facts

Active ingredient

Ethyl alcohol 62%

Purpose

Antiseptic

Uses

• hand sanitizer to decrease bacteria on the skin
• recommended for repeated use
• for use when soap and water are not available

Warnings

Flammable, keep away from fire/flame

For external use only

Do not use

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


When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water


Stop use and ask a doctor if

• irritation or redness develop
• condition persists for more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• wet hands thoroughly with product and allow to dry without wiping
• supervise children under 6 years of age when using this product to avoid swallowing

Other information

• store between 15-30°C (59-86°F)
• avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

water, hydroxyethyl cellulose, fragrance, glycerin, betaine, propanediol, sodium hydroxide, aloe vera (Aloe barbadensis) leaf juice, tocopheryl acetate (vitamin E acetate)

Questions?

+1-800-889-3489
You may also report serious side effects to this phone number.
Mon-Fri 9:00 AM — 5:00 PM

♦ With Moisturizers, Aloe, and Vitamin E
♦ Lemongrass Fragrance
♦ Skin Conditioners
♦ Quick Dry
♦ Smooth Silky Feel

Manufactured by:
AMERICAN CHEMICAL SYSTEMS II, LLC
3505 W. 29th Street South, Wichita, Kansas 67217

READ PRECAUTIONS CAREFULLY

Safety Data Sheet (SDS) is available at:

americanchemicalsystemsii.com

Packaging

untitled
(click image for full-size original)

ACS GOLDEN TOUCH ANTISEPTIC HAND SANITIZER ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75044-261
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 62 L in 100 L
Inactive Ingredients
Ingredient Name Strength
WATER
HYDROXYETHYL CELLULOSE, UNSPECIFIED
GLYCERIN
BETAINE
PROPANEDIOL
SODIUM HYDROXIDE
ALOE VERA LEAF
.ALPHA.-TOCOPHEROL ACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75044-261-57 3.8 L in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 06/01/2020
Labeler — American Chemical Systems II, LLC (016631058)
Establishment
Name Address ID/FEI Operations
American Chemical Systems II, LLC 016631058 manufacture (75044-261)

Revised: 05/2020 American Chemical Systems II, LLC

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