FIRST AID BEAUTY FAB ULTRA REPAIR BODY SKIN PROTECTANT COOLING CUCUMBER- colloidal oatmeal lotion

First Aid Beauty FAB Ultra Repair Body Skin Protectant Cooling Cucumber by

Drug Labeling and Warnings

First Aid Beauty FAB Ultra Repair Body Skin Protectant Cooling Cucumber by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Colloidal Oatmeal 0.5%

Purpose

Skin Protectant

Uses

• Temporarily protects and helps relieve minor skin irritation and itching due to eczema, rashes, poison ivy, oak or sumac, insect bites

Warnings

For external use only.

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

Do not get into eyes.

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days

Directions

Apply as needed

INACTIVE INGREDIENT

Water, glycerin, C12-15 alkyl benzoate, caprylic/capric triglyceride, stearic acid, glyceryl stearate, glyceryl stearate SE, butyrospermum parkii (shea) butter, dimethicone, squalane, allantoin, camellia sinensis leaf extract, caprylyl glycol, ceramide NP, cetearyl alcohol, chrysanthemum parthenium (feverfew) extract, cucumis melo (melon) fruit extract, cucumis sativus (cucumber) fruit extract, disodium EDTA, glycyrrhiza glabra (licorice) root extract, phenoxyethanol, prunus armeniaca (apricot) fruit extract, pyrus malus (apple) fruit extract, rose extract, rubus idaeus (raspberry) fruit extract, santalum album (sandalwood) wood extract, sodium hydroxide, tetrasodium EDTA, xanthan gum

Questions:

888-FAB-3063

SPL UNCLASSIFIED SECTION

MADE IN USA

FIRST AID BEAUTY LTD

NEWTON, MA 02458

WWW.FIRSTAIDBEAUTY.COM

PRINCIPAL DISPLAY PANEL - 283.5 g (10 oz)

First Aid Beauty

FAB

Ultra Repair Body Lotion

Lightweight, Daily Hydration

Skin Protectant Colloidal Oatmeal

Cooling Cucumber

Net Wt. 283.5 g (10 oz)

INGREDIENTS AND APPEARANCE

FIRST AID BEAUTY FAB ULTRA REPAIR BODY SKIN PROTECTANT COOLING CUCUMBER 
colloidal oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-727
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CUCUMBER (UNII: YY7C30VXJT)
APRICOT (UNII: 269CJD5GZ9)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SQUALANE (UNII: GW89575KF9)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SHEA BUTTER (UNII: K49155WL9Y)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALLANTOIN (UNII: 344S277G0Z)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STEARIC ACID (UNII: 4ELV7Z65AP)
XANTHAN GUM (UNII: TTV12P4NEE)
CERAMIDE NP (UNII: 4370DF050B)
TANACETUM PARTHENIUM (UNII: 6GE7Z0761K)
SANDALWOOD (UNII: 3641YW25N2)
RASPBERRY (UNII: 4N14V5R27W)
APPLE (UNII: B423VGH5S9)
MUSKMELON (UNII: ZV095H5633)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-727-28	283.5 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/15/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	07/15/2023

Labeler - The Procter & Gamble Manufacturing Company (004238200)