drug facts

drug facts
SPL v4
SPL
SPL Set ID fefbe351-1cd9-4a2f-a43d-51e2c4eb180b
Route
topical
Published
Effective Date 2013-09-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (2 g) zinc cation (0.1 g)
Inactive Ingredients
cetyl alcohol glyceryl monostearate laureth-23 methylparaben mineral oil petrolatum propylene glycol propylparaben stearic acid stearyl alcohol water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2013-11-01

Description

Inactive Ingredients - cetyl alcohol, glycerol stearate, laureth-23, methylparaben, mineral oil, petrolatum, propylene glycol, propylparaben, stearic acid, stearyl alcohol, water


Medication Information

Warnings and Precautions

Warnings

For external use only

Active Ingredient

Active Ingredients

Diphenhydramine hydrochloride 2 %

Zinc acetate 0.1 %

Indications and Usage

Uses  for temporary relief from pain and itching associated

with insect bites, sunburn and minor skin irritations. Dries the

oozing and weeping of poison: -ivy -oak - sumac

Dosage and Administration

Directions

-for adults and children over 2 years of age: apply to affected area

not more than 3 or 4 times per day

-children under 2 years of age: ask a doctor before use

Description

Inactive Ingredients - cetyl alcohol, glycerol stearate, laureth-23, methylparaben, mineral oil, petrolatum, propylene glycol, propylparaben, stearic acid, stearyl alcohol, water

Section 44425-7

Other information - store at room temperature 59 - 86 F (15 - 30 C)

Section 50565-1

Keep out of reach of children. If swallowed, get medical help

or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if:

-symptoms last for more than 7 days

-the condition gets worse

-symptoms clear up and then occur again within a few days

Section 50567-7

When using this product - avoid contact with eyes

Section 50569-3

Ask a doctor before use

-on chicken pox

-on measles

Section 50570-1

Do not use

-over large areas of the body

-with any other product containing diphenhydramine,

including those taken orally

Section 51727-6

Inactive Ingredients - cetyl alcohol, glycerol stearate,

laureth-23, methylparaben, mineral oil, petrolatum, propylene

glycol, propylparaben, stearic acid, stearyl alcohol, water

Section 51945-4

Section 53413-1

Questions? 1-800-639-3803 Weekdays 9 AM to 4 PM EST

Section 55105-1

Purpose

---Topical analgesic

---Skin protectant


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Active Ingredient (55106-9)

Active Ingredients

Diphenhydramine hydrochloride 2 %

Zinc acetate 0.1 %

Indications and Usage (34067-9)

Uses  for temporary relief from pain and itching associated

with insect bites, sunburn and minor skin irritations. Dries the

oozing and weeping of poison: -ivy -oak - sumac

Dosage and Administration (34068-7)

Directions

-for adults and children over 2 years of age: apply to affected area

not more than 3 or 4 times per day

-children under 2 years of age: ask a doctor before use

Section 44425-7 (44425-7)

Other information - store at room temperature 59 - 86 F (15 - 30 C)

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 50566-9 (50566-9)

Stop use and ask a doctor if:

-symptoms last for more than 7 days

-the condition gets worse

-symptoms clear up and then occur again within a few days

Section 50567-7 (50567-7)

When using this product - avoid contact with eyes

Section 50569-3 (50569-3)

Ask a doctor before use

-on chicken pox

-on measles

Section 50570-1 (50570-1)

Do not use

-over large areas of the body

-with any other product containing diphenhydramine,

including those taken orally

Section 51727-6 (51727-6)

Inactive Ingredients - cetyl alcohol, glycerol stearate,

laureth-23, methylparaben, mineral oil, petrolatum, propylene

glycol, propylparaben, stearic acid, stearyl alcohol, water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? 1-800-639-3803 Weekdays 9 AM to 4 PM EST

Section 55105-1 (55105-1)

Purpose

---Topical analgesic

---Skin protectant


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)