A+ Health Itch Relief Gel

A+ Health Itch Relief Gel
SPL v1
SPL
SPL Set ID 38040732-48c9-3533-e063-6394a90af10a
Route
TOPICAL
Published
Effective Date 2025-06-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (2 mg)
Inactive Ingredients
Methylparaben Propylparaben Propylene Glycol Alcohol Diazolidinyl Urea Sodium Citrate Water Glycerin Anhydrous Citric Acid Camphor (synthetic) Hypromellose, Unspecified

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-20

Description

Diphenhydramine HCl 2%

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

Diphenhydramine HCl 2%

Uses

Temporarily relieves pain due to: • minor burns • insect bites

• sunburn • minor skin irritation • minor cuts • scrapes • rashes

due to poison ivy, poison oak & poison sumac

Section 42229-5

DISTRIBUTED BY: Bionpharma Inc., Princeton, NJ 08540

L0000940 R0125

†This product is not manufactured or distributed by the owner of the registered trademark Benadryl†®

Warnings

For external use only.

Directions

• do not use more often than directed • adults and

children 2 years of age and older:
apply to affected area not more than

3 to 4 times daily • children under 2 years of age: ask a doctor.

Do Not Use

• on large areas of the body • with any other product containing diphenhydramine, even one taken by mouth

Active Ingredient

Diphenhydramine HCl 2%

Inactive Ingredients

Camphor, Citric Acid, Diazolidnyl Urea,

Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Propylene

Glycol, Propylparaben, SD Alcohol 38-B, Sodium Citrate, Purified Water.

4 Fl Oz (118 Ml) Tube

Compare to the active ingredient

in Benadryl ® Gel

a+ health TM

extra strength

itch

relief

gel

diphenhydramine HCl 2%

topical analgesic

cooling itch relief

for insect bites

& poison ivy/oak/

sumac rashes

4 fl oz (118 mL)

DO NOT USE IF FOIL UNDER CAP IS BROKEN OR MISSING

Ask A Doctor Before Use

• on chicken pox • measles

Questions and Comments?

call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

When Using This Product

• avoid contact with eyes

Stop Use and Ask A Doctor If

• condition gets worse • symptoms last for more than 7 days • symptoms clear up and occur again in a few days.

Keep Out of Reach of Children

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


Structured Label Content

Uses

Temporarily relieves pain due to: • minor burns • insect bites

• sunburn • minor skin irritation • minor cuts • scrapes • rashes

due to poison ivy, poison oak & poison sumac

Section 42229-5 (42229-5)

DISTRIBUTED BY: Bionpharma Inc., Princeton, NJ 08540

L0000940 R0125

†This product is not manufactured or distributed by the owner of the registered trademark Benadryl†®

Purpose

External analgesic

Warnings

For external use only.

Directions

• do not use more often than directed • adults and

children 2 years of age and older:
apply to affected area not more than

3 to 4 times daily • children under 2 years of age: ask a doctor.

Do Not Use (Do not use)

• on large areas of the body • with any other product containing diphenhydramine, even one taken by mouth

Active Ingredient

Diphenhydramine HCl 2%

Inactive Ingredients (Inactive ingredients)

Camphor, Citric Acid, Diazolidnyl Urea,

Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Propylene

Glycol, Propylparaben, SD Alcohol 38-B, Sodium Citrate, Purified Water.

4 Fl Oz (118 Ml) Tube (4 fl oz (118 mL) tube)

Compare to the active ingredient

in Benadryl ® Gel

a+ health TM

extra strength

itch

relief

gel

diphenhydramine HCl 2%

topical analgesic

cooling itch relief

for insect bites

& poison ivy/oak/

sumac rashes

4 fl oz (118 mL)

DO NOT USE IF FOIL UNDER CAP IS BROKEN OR MISSING

Ask A Doctor Before Use (Ask a doctor before use)

• on chicken pox • measles

Questions and Comments? (Questions and comments?)

call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

When Using This Product (When using this product)

• avoid contact with eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• condition gets worse • symptoms last for more than 7 days • symptoms clear up and occur again in 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.


Advanced Ingredient Data


Raw Label Data

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