Dermachange Aid Anti-itch Gel, Diphenhydramine Hcl 2%

Dermachange Aid Anti-itch Gel, Diphenhydramine Hcl 2%
SPL v1
SPL
SPL Set ID 12ed906c-d028-0ff7-e063-6394a90aaa52
Route
TOPICAL
Published
Effective Date 2024-03-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (2 g)
Inactive Ingredients
Camphor (synthetic) Hypromelloses Glycerin Alcohol Ethylhexylglycerin Water Citric Acid Monohydrate Phenoxyethanol Propylene Glycol Sodium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-31

Description

Diphenhydramine HCl 2%


Medication Information

Warnings and Precautions

For external use only. Do not use on large areas of the body, with any other products containing diphenhydramine, even one taken by mouth. When using this product avoid contact with eyes. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

Indications and Usage

For the temporary relief of pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, and rashes due to poison ivy, oak, and sumac.

Dosage and Administration

Do not use more than directed. Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

Description

Diphenhydramine HCl 2%

Section 50565-1

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

Section 51727-6

Camphor, Citric Acid, Ethylhexylglycerin, Glycerin, Hydroxypropyl Methylcellulose, Phenoxyethanol, Propylene Glycol, SD Alcohol 38-B, Sodium Citrate, Water.

Section 51945-4

Section 55105-1



Topical Analgesic.

Section 55106-9

Diphenhydramine HCl 2%


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, and rashes due to poison ivy, oak, and sumac.

Dosage and Administration (34068-7)

Do not use more than directed. Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

Warnings and Precautions (34071-1)

For external use only. Do not use on large areas of the body, with any other products containing diphenhydramine, even one taken by mouth. When using this product avoid contact with eyes. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Camphor, Citric Acid, Ethylhexylglycerin, Glycerin, Hydroxypropyl Methylcellulose, Phenoxyethanol, Propylene Glycol, SD Alcohol 38-B, Sodium Citrate, Water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)



Topical Analgesic.

Section 55106-9 (55106-9)

Diphenhydramine HCl 2%


Advanced Ingredient Data


Raw Label Data

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