SPL v8
SPL
SPL Set ID 82011efe-825c-4102-b6f1-59eff4c8040a
Route
TOPICAL
Published
Effective Date 2025-06-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (1 g) Menthol (0.5 g)
Inactive Ingredients
Glycerin Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2000-04-26

Description

Drug Facts

Purpose

Antihistamine External Analgesic


Medication Information

Purpose

Antihistamine

External Analgesic

Description

Drug Facts

Uses

Temporary relief of itching associate with insect bite

Section 42229-5

Drug Facts

Warnings

For external use only

Flammable keep away from fire or flame

Directions

Adults and children 6 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 6 years of age: Do not use, consult a doctor.

Do Not Use On
  • wounds
  • damaged skin
Other Information
  • Store at room temperature under 86°F (30°C)
  • Flammable. keep away from fire or flame
Active Ingredients

Diphenhydramine Hydrochloride 2%

Menthol 1%

Inactive Ingredients

Glycerin

Geraniol-denatured Alcohol

Questions and Comments

Call 1-310-661-7260 Mon.-Fri. (2p.m. - 3p.m. PST)

When Using This Product
  • avoid contact with the eyes and mouth
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
Keep Out of Reach of Children.

If swallowed, get medical help or contact.“a Poison Control Center right away.”

Principal Display Panel 50 Ml Bottle Label

NDC 51027-0330-2

KINKAN

COOL

Liniment

EXTERNAL

ANTIPRURITIC

LINIMENT

MANUFACTURED BY

KINKANDO CO., LTD.350-2 KODAMACHOKYOEI,

HONJO-SHI, SAITAMA 367-0206,

JAPAN

DISTRIBUTED BY

PMAI21112 Figueroa Street Unit B

Carson, CA 90745

1.7 FL OZ (50mL)


Structured Label Content

Uses

Temporary relief of itching associate with insect bite

Section 42229-5 (42229-5)

Drug Facts

Purpose

Antihistamine

External Analgesic

Warnings

For external use only

Flammable keep away from fire or flame

Directions

Adults and children 6 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 6 years of age: Do not use, consult a doctor.

Do Not Use On (Do not use on)
  • wounds
  • damaged skin
Other Information
  • Store at room temperature under 86°F (30°C)
  • Flammable. keep away from fire or flame
Active Ingredients (Active ingredients)

Diphenhydramine Hydrochloride 2%

Menthol 1%

Inactive Ingredients (Inactive ingredients)

Glycerin

Geraniol-denatured Alcohol

Questions and Comments (Questions and comments)

Call 1-310-661-7260 Mon.-Fri. (2p.m. - 3p.m. PST)

When Using This Product (When using this product)
  • avoid contact with the eyes and mouth
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact.“a Poison Control Center right away.”

Principal Display Panel 50 Ml Bottle Label (Principal Display Panel - 50 mL Bottle Label)

NDC 51027-0330-2

KINKAN

COOL

Liniment

EXTERNAL

ANTIPRURITIC

LINIMENT

MANUFACTURED BY

KINKANDO CO., LTD.350-2 KODAMACHOKYOEI,

HONJO-SHI, SAITAMA 367-0206,

JAPAN

DISTRIBUTED BY

PMAI21112 Figueroa Street Unit B

Carson, CA 90745

1.7 FL OZ (50mL)


Advanced Ingredient Data


Raw Label Data

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