HYDROCORTISONE- hydrocortisone liquid
American Spraytech, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Hydrocortisone

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

For the temporary relief of itching associatd with minor skin irritations, inflammation, and rashes due to: • eczema • insect bites • poison ivy • poison oak • poison sumac soaps • jewelry • detergents • cosmetics • seborrheic dermatitis • psonasis • other uses of this product should be only under the advice and supervision of doctor

Warnings

For external use only.

Flammable: Keep away from heat, sparks and open flame. Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120° F. Interntional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

Do not use

for external genital, vaginal or anal itching
with other hydrocortisone product unless consulted by a doctor
in or near the eyes
for diaper rash

When using this product

avoid contact with the eyes
if product gets into the eye, flush with water for 15 minutes

Stop use and ask a doctor if

condition worsens
symptoms persist for more than 7 days or 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.

Directions

twist cap left to unlock actuator
adults and children 2 years of age and older: spray affected area not more than 3 to 4 times daily
children under 2 years of age: do not use, consult a doctor
to apply to face, spray into palm of hand and gently apply

Other information

store between 20° and 25°C (68° and 77°F)

Inactive ingredients

aloe barbadensis leaf juice, avena sativa (oat) kernel extract, citric acid, disodium EDTA, ethoxydiglycol, glycerin, malliodextrin, menthyl lactate, methyl gluceth-20, PEG-8, SD alcohol 40-B, sodium citrate, water

Questions?

Call 1-888-287-1915

Package Labeling:

Label4

HYDROCORTISONE
hydrocortisone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68754-206
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OAT (UNII: Z6J799EAJK)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
GLYCERIN (UNII: PDC6A3C0OX)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68754-206-00	113 g in 1 BOX; Type 0: Not a Combination Product	12/26/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	12/26/2017

Labeler - American Spraytech, LLC (137135237)

Revised: 12/2017

Document Id: 615773bc-0899-fc39-e053-2a91aa0af00f

Set id: a88ef94d-5e30-4e70-b43d-7fa5fb3f8ef0

Version: 1

Effective Time: 20171227

American Spraytech, LLC