instant sanitizing wipes

instant sanitizing wipes
SPL v1
SPL
SPL Set ID a96ff670-0ad9-6281-e053-2995a90a33ab
Route
topical
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (0.00004 U)
Inactive Ingredients
silver acetate chlorhexidine acetate benzalkonium chloride water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-07-02

Purpose

Antibacterial

Description

Alcohol 75% v/v; Chlorohexidine Diacetate 0.1% v/v; Benzalkonium 0.1% v/v;


Medication Information

Warnings

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

Purpose

Antibacterial

Directions

Directions

• To Open Package: Unscrew lid to remove.

• Open foil bag.

• Locate wipe in the center and insert corner of the wipe through opening in lid.

• DO NOT PUSH FINGER THROUGH OPENING.

• Replace lid.

• Pull sheet up slightly to side. Always snap lid cap securely shut between uses to prevent moisture loss.

Other Information
  • Store between 15-30℃ (59-86F)
  • Avoid freezing and excessive heat about 40℃ (104F)
Inactive Ingredients

Water, Chlorhexidine Diacetate, Benzalkonium Chloride, Nano Silver Ions, Vitamin E

Description

Alcohol 75% v/v; Chlorohexidine Diacetate 0.1% v/v; Benzalkonium 0.1% v/v;

Use

• For hand washing to decrease bacteria on the skin.

• Apply topically to the skin to help prevent cross contamination.

• Recommended for repeated use.

• Dries in seconds when used as directed.

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if irritation or rash appears and lasts.

Section 50567-7

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Do Not Use
  • on infants less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

Alcohol 75% v/v;

Chlorohexidine Diacetate 0.1% v/v;

Benzalkonium 0.1% v/v;

Package Label Principal Display Panel

20 wipes in 1 bag. NDC: 78183-003-01;

100 wipes in 1 bag. NDC: 78183-003-02;


Structured Label Content

Warnings

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

Purpose

Antibacterial

Directions

Directions

• To Open Package: Unscrew lid to remove.

• Open foil bag.

• Locate wipe in the center and insert corner of the wipe through opening in lid.

• DO NOT PUSH FINGER THROUGH OPENING.

• Replace lid.

• Pull sheet up slightly to side. Always snap lid cap securely shut between uses to prevent moisture loss.

Other Information (Other information)
  • Store between 15-30℃ (59-86F)
  • Avoid freezing and excessive heat about 40℃ (104F)
Inactive Ingredients (Inactive ingredients)

Water, Chlorhexidine Diacetate, Benzalkonium Chloride, Nano Silver Ions, Vitamin E

Use

• For hand washing to decrease bacteria on the skin.

• Apply topically to the skin to help prevent cross contamination.

• Recommended for repeated use.

• Dries in seconds when used as directed.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash appears and lasts.

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Do Not Use (Do not use)
  • on infants less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

Alcohol 75% v/v;

Chlorohexidine Diacetate 0.1% v/v;

Benzalkonium 0.1% v/v;

Package Label Principal Display Panel (Package Label - Principal Display Panel)

20 wipes in 1 bag. NDC: 78183-003-01;

100 wipes in 1 bag. NDC: 78183-003-02;


Advanced Ingredient Data


Raw Label Data

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