71745-003 Goodearth Sanitizing Wipes

71745-003 Goodearth Sanitizing Wipes
SPL v3
SPL
SPL Set ID 1c4ec3cb-b7a4-73c9-e063-6394a90afeda
Route
TOPICAL
Published
Effective Date 2024-07-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (3.822 mg)
Inactive Ingredients
Propylene Glycol Dehydroacetic Acid Poly(laurylglucoside)-7 Benzoic Acid Water Phenoxyethanol Caprylyl/capryl Oligoglucoside

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-11

Description

Active Ingredient Benzalkonium Chloride 0.13 %


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Use

Hand sanitizer to help reduce bacteria on the skin.

Recommended for repeated use.

Dosage and Administration

Directions

· Wet hands thoroughly with product and allow to dry.

· Be sure to use entire wipe.

· Discard after single use.

· Children under 6 years of age should be supervised

when using this product.

Description

Active Ingredient Benzalkonium Chloride 0.13 %

Section 50565-1

Keep out of reach of children.

Section 50566-9

Discontinue use if irritation and redness develop.

If conditions persist for more than 72 hours, consult a physician.

If swallowed get medical help or contact a poison control

center immediately.

Section 50567-7

When using this product do not use in or near the eyes.

In case of contact, rinse eyes thoroughly in water.

Section 51727-6

Inactive Ingredients

Benzoic Acid, Caprylyl/Capryl Oligoglucoside, Dehydroacetic Acid, Phenoxyethanol, Poly(Laurylglucoside)-7, Propylene Glycol, Water

Section 51945-4

3000 Total Wipes (1500 wipes per roll; 2 rolls per case)

NDC: 71745-003-01

Section 55105-1

Purpose

Antimicrobial

Section 55106-9

Active Ingredient

Benzalkonium Chloride 0.13 %


Structured Label Content

Indications and Usage (34067-9)

Use

Hand sanitizer to help reduce bacteria on the skin.

Recommended for repeated use.

Dosage and Administration (34068-7)

Directions

· Wet hands thoroughly with product and allow to dry.

· Be sure to use entire wipe.

· Discard after single use.

· Children under 6 years of age should be supervised

when using this product.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Discontinue use if irritation and redness develop.

If conditions persist for more than 72 hours, consult a physician.

If swallowed get medical help or contact a poison control

center immediately.

Section 50567-7 (50567-7)

When using this product do not use in or near the eyes.

In case of contact, rinse eyes thoroughly in water.

Section 51727-6 (51727-6)

Inactive Ingredients

Benzoic Acid, Caprylyl/Capryl Oligoglucoside, Dehydroacetic Acid, Phenoxyethanol, Poly(Laurylglucoside)-7, Propylene Glycol, Water

Section 51945-4 (51945-4)

3000 Total Wipes (1500 wipes per roll; 2 rolls per case)

NDC: 71745-003-01

Section 55105-1 (55105-1)

Purpose

Antimicrobial

Section 55106-9 (55106-9)

Active Ingredient

Benzalkonium Chloride 0.13 %


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)