Clean Care (Elements) Hand Sanitizer: Package Insert and Label Information

CLEAN CARE (ELEMENTS) HAND SANITIZER- alcohol gel
URBANBCL 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.

ethyl alcohol

to decrease bacteria on the skin that could cause disease

recommended for repeated use

KEEP OUT OF REACH OF THE CHILDREN

■ Flammable. Keep away from fire or flame.

■ For external use only.

■ Do not use in eyes.

■ lf swallowed, get medical help promptly.

■ Stop use, ask doctor lf irritation occurs.

■ Keep out of reach of children.

for external use only

water, trolamine, dipropylene glycol, carbomer

wet hands thoroughly with product and allow to dry without wiping

for children under 6, use only under adult supervision

not recommended for infants

label
(click image for full-size original)

CLEAN CARE (ELEMENTS) HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74200-0020
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 75 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
TROLAMINE
WATER
CARBOMER 940
DIPROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74200-0020-1 500 mL in 1 BOTTLE None
2 NDC:74200-0020-2 236.6 mL in 1 BOTTLE None
3 NDC:74200-0020-3 100 mL in 1 BOTTLE None
4 NDC:74200-0020-4 60 mL in 1 BOTTLE None
5 NDC:74200-0020-5 1000 mL in 1 BOTTLE None
6 NDC:74200-0020-6 2000 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 04/01/2020
Labeler — URBANBCL CO LTD (694794065)
Registrant — URBANBCL CO LTD (694794065)
Establishment
Name Address ID/FEI Operations
URBANBCL CO LTD 694794065 manufacture (74200-0020)

Revised: 05/2020 URBANBCL CO LTD

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