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Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (20 mg)

Inactive Ingredients

Cetyl Alcohol Glyceryl Monostearate Peg-100 Stearate Methylparaben Propylene Glycol Propylparaben Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2005-09-20

Medication Information

Description

Drug Facts

Uses

temporarily relieves pain and itching associated with:

insect bites
minor burns
sunburn
minor skin irritations
minor cuts
scrapes
rashes due to poison ivy, poison oak, and poison sumac
dries the oozing and weeping of poison ivy, poison oak, and poison sumac

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50567-7

When using this product avoid contact with eyes

Section 55105-1

Active ingredients	Purpose
Diphenhydramine hydrochloride 2%	Topical analgesic
Zinc acetate 0.1%	Skin protectant

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

Questions?

Call 1-866-923-4914

Other Information

To open: unscrew cap, use pointed end of cap to puncture seal.
store at 20° to 25°C (68° to 77°F)
see carton or tube crimp for lot number and expiration date

Inactive Ingredients

cetyl alcohol, glyceryl stearate, glyceryl stearate/PEG-100 stearate, methylparaben, propylene glycol, propylparaben and purified water

Ask A Doctor Before Use

on chicken pox
on measles

Stop Use and Ask A Doctor If

condition worsens or does not improve within 7 days
symptoms persist for more than 7 days or clear up and occur again within a few days

Principal Display Panel 28.4 G Tube Carton

Extra Strength

Anti-Itch Cream

DIPHENHYDRAMINE HYDROCHLORIDE 2%

AND ZINC ACETATE 0.1%

■ TOPICAL ANALGESIC ■ SKIN PROTECTANT

NET WT 1 OZ (28.4g)

Structured Label Content

Uses

temporarily relieves pain and itching associated with:

insect bites
minor burns
sunburn
minor skin irritations
minor cuts
scrapes
rashes due to poison ivy, poison oak, and poison sumac
dries the oozing and weeping of poison ivy, poison oak, and poison sumac

Section 42229-5 (42229-5)

Drug Facts

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 50567-7 (50567-7)

When using this product avoid contact with eyes

Section 55105-1 (55105-1)

Active ingredients	Purpose
Diphenhydramine hydrochloride 2%	Topical analgesic
Zinc acetate 0.1%	Skin protectant

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

Questions?

Call 1-866-923-4914

Other Information (Other information)

To open: unscrew cap, use pointed end of cap to puncture seal.
store at 20° to 25°C (68° to 77°F)
see carton or tube crimp for lot number and expiration date

Inactive Ingredients (Inactive ingredients)

cetyl alcohol, glyceryl stearate, glyceryl stearate/PEG-100 stearate, methylparaben, propylene glycol, propylparaben and purified water

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

on chicken pox
on measles

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

condition worsens or does not improve within 7 days
symptoms persist for more than 7 days or clear up and occur again within a few days

Principal Display Panel 28.4 G Tube Carton (PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton)

Extra Strength

Anti-Itch Cream

DIPHENHYDRAMINE HYDROCHLORIDE 2%

AND ZINC ACETATE 0.1%

■ TOPICAL ANALGESIC ■ SKIN PROTECTANT

NET WT 1 OZ (28.4g)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves pain and itching associated with: insect bites minor burns sunburn minor skin irritations minor cuts scrapes rashes due to poison ivy, poison oak, and poison sumac dries the oozing and weeping of poison ivy, poison oak, and poison sumac", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50567-7": "When using this product avoid contact with eyes", "55105-1": "Active ingredients Purpose Diphenhydramine hydrochloride 2% Topical analgesic Zinc acetate 0.1% Skin protectant", "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", "Questions?": "Call 1-866-923-4914", "Other information": "To open: unscrew cap, use pointed end of cap to puncture seal. store at 20° to 25°C (68° to 77°F) see carton or tube crimp for lot number and expiration date", "Inactive ingredients": "cetyl alcohol, glyceryl stearate, glyceryl stearate/PEG-100 stearate, methylparaben, propylene glycol, propylparaben and purified water", "Ask a doctor before use": "on chicken pox on measles", "Stop use and ask a doctor if": "condition worsens or does not improve within 7 days symptoms persist for more than 7 days or clear up and occur again within a few days", "PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton": "Extra Strength Anti-Itch Cream DIPHENHYDRAMINE HYDROCHLORIDE 2% AND ZINC ACETATE 0.1% ■ TOPICAL ANALGESIC ■ SKIN PROTECTANT NET WT 1 OZ (28.4g)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information