OTC Medication Information: CALA ADVANCED HAND SANITIZING TISSUES

CALA ADVANCED HAND SANITIZING TISSUES- alcohol swab
Shin’s Trading Co., Inc. Dba Cala Products

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[s]

Alcohol 70% v/v

Purpose

Antimicrobial

Use[s]

■ to reduce germs on the skin that could cause disease ■ recommended for repeated use.

Warnings

For external use only

Flammable. Keep away from heat or flame.

Do not use ■ in or near the eyes. In case of contact, rinse eyes thoroughly with water.

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

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 dry. ■ Reseal tissues after each use to avoid product from drying. ■ Supervise children under 6 years of age when using this product.

Other Information ■ Store between 15°C to 30°C(59°F to 86°F) ■ Avoid freezing and excessive heat above 40°C(104°F)

Inactive ingredients Water, Glycerin, Hydroxyacetophenone, Cetylpyridinium Chloride, Citric Acid Monohydrate, Butylene Glycol, Aloe Ferox Leaf Extract

Questions or Comments?

1-231-745-5141

SANITIZING & REFRESHING

CLEAN HANDS

WITH ALOE VERA EXTRACT

Pre-moistened Santizing Tissues

5.9 x 7.9 in (15 x 20 cm)

MADE IN KOREA

Cleansing & Refreshing

ADVANCED HAND SANITIZING TISSUES

CAUTIONS: FOR EXTERNAL USE ONLY. If any product gets into eyes it may cause irritation, rinse eyes thoroughly with warm water. KEEP OUT OF REACH OF CHILDREN.

CALA® PRODUCTS

LOS ANGELES, CA 90007 U.S.A.

www.calaproduct.com

MADE IN SOUTH KOREA

Packaging

IMAGE
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IMAGE
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CALA ADVANCED HAND SANITIZING TISSUES
alcohol swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74985-678
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
WATER
GLYCERIN
HYDROXYACETOPHENONE
CETYLPYRIDINIUM CHLORIDE
CITRIC ACID MONOHYDRATE
BUTYLENE GLYCOL
ALOE FEROX LEAF
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74985-678-55 30 PACKET in 1 POUCH contains a PACKET
1 4.19 mL in 1 PACKET This package is contained within the POUCH (74985-678-55)
2 NDC:74985-678-56 60 PACKET in 1 POUCH contains a PACKET
2 4.65 mL in 1 PACKET This package is contained within the POUCH (74985-678-56)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 05/07/2020
Labeler — Shin’s Trading Co., Inc. Dba Cala Products (175832021)

Revised: 09/2020 Shin’s Trading Co., Inc. Dba Cala Products

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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